US Stem Cell Inc (USRM)

[Dragon Lady]

FDA Comella/USCC "WARNING LETTER" SERIOUS...uh oh..

LETS JUST STICK WITH THE FACTS HERE EH...REALITY....this is from the FEDS...not some freaking little propaganda "movie" being hyped or some damn INSTAGRAM blah blah "fitness dude" who doesn't know FDA regulations or law from a bottle of muscle milk he peddles or whatever...WTH qualifications does that dude have to comment about ANYTHING regarding the FDA...anymore than my gardener or local pool man..who probably have a few IQ points on the "fitness dude" promoter....

SO TO ME....LETS REMEMBER THE "REAL NEWS" and main driver affecting this lil nano cap PENNY SPECIAL RIGHT NOW IMO...and dat be thee FDA, aka THEE FEDERAL GOVT and not any happy bloggy tales stories or whatever....THIS NEWS, a serious "FDA WARNING" literally went WORLD WIDE...versus how many readers does one think the bloggy happy tales version gets, LOL ??? I'd say probably a 100,000 to 1, maybe even a MILLION to 1 "readership" ratio...easily...as the TOP GOOGLE SEARCH RESULTS for any term(s) such as, "U.S. Stem Cell Clinic" or "U.S. Stem Cell Florida" or "Kristin Comella" return ON PAGE ONE/PAGE TWO SEARCH RESULTS such items as the FDA GOVERNMENT SITE WARNING LETTER LINKS below, the TIME mag stories, "THREE BLIND LADIES" stories in every major news publication and the "WARNING LETTER" also in major, major news (real news) outlets such as NPR, CNN, NY Times, Web MD, LA Times, CBS news, The Washington Post, and on and on and on.....

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm573431.htm

https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm573187.htm

https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-afda-orgs/documents/document/ucm572416.pdf


QUOTE:

FDA News Release

FDA warns US Stem Cell Clinic of significant deviations

For Immediate Release
August 28, 2017

Release
The U.S. Food and Drug Administration today posted a warning letter issued to US Stem Cell Clinic of Sunrise, Florida, and its Chief Scientific Officer Kristin Comella for marketing stem cell products without FDA approval and for significant deviations from current good manufacturing practice requirements, including some that could impact the sterility of their products, putting patients at risk.
“Stem cell clinics that mislead vulnerable patients into believing they are being given safe, effective treatments that are in full compliance with the law are dangerously exploiting consumers and putting their health at risk,” said FDA Commissioner Scott Gottlieb, M.D. “As the FDA takes new steps to advance an efficient, modern approach to the regulation of cell based regenerative medicine, at the same time we will be stepping up our enforcement actions against clinics that abuse the trust of patients and, more important, endanger their health with unsanitary conditions or by purporting to have treatments which may not provide any benefit.”

The FDA recently inspected US Stem Cell Clinic and found that the clinic was processing adipose tissue (body fat) into stromal vascular fraction (stem cells derived from body fat) and administering the product both intravenously or directly into the spinal cord of patients to treat a variety of serious diseases or conditions, including Parkinson’s disease, amyotrophic lateral sclerosis (ALS), chronic obstructive pulmonary disease (COPD), heart disease and pulmonary fibrosis. The FDA has not reviewed or approved any biological products manufactured by US Stem Cell Clinic for any use.

“Our aim is to provide an efficient route to market for promising technologies,” Gottlieb continued. “But at the same time, we will take a firm stance against those that prey on the medical promise of regenerative cell therapies to market treatments potentially unsafe or unproven so-called cures. We want a regulatory framework that helps efficiently and effectively advance the many promising technologies in the field of regenerative cell therapies. The FDA can’t allow a small number of bad actors to leverage that promise to mislead patients and put them at risk.”

During the inspection, FDA investigators also documented evidence of significant deviations from current good manufacturing practices in the manufacture of at least 256 lots of stem cell products by the clinic. For example, the firm was cited for its failure to establish and follow appropriate written procedures designed to prevent microbiological contamination of products purporting to be sterile, which puts patients at risk for infections.

US Stem Cell Clinic also tried to impede the FDA’s investigation during the most recent inspection by refusing to allow entry except by appointment and by denying FDA investigators access to employees. Refusing to permit entry or FDA inspection is a violation of federal law.

The FDA has requested a response from US Stem Cell Clinic, including a statement of how the deviations noted in the warning letter will be corrected, within 15 working days. Companies that do not correct deviations risk additional enforcement action such as seizure, injunction, or prosecutions.

Health care professionals and consumers should report any adverse events related to treatments provided by US Stem Cell Clinic to the FDA’s MedWatch Adverse Event Reporting program. To file a report, use the MedWatch Online Voluntary Reporting Form. The completed form can be submitted online or via fax to 1-800-FDA-0178.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
"

THEN...Comella had already received SEVERAL "483 INSPECTIONAL WARNINGS" which of course led to the "FORMAL WARNING LETTER"...a very serious event....

USCC/Comella MULTIPLE FDA 483 WARNINGS !

Was wondering where the FORM 483's were. I'd checked the FDA site where they post 483's, and had not found any for USRM/Comella/USSC in the past...but shazam, it's there now.

One of them 483 warnings is now up on the FDA's public website. AND, it shows/states that the clinic was inspected by the FDA much earlier, 12/7/2015 and received FDA 483 WARNING THEN, to which they obviously did not properly respond, nor heed, nor correct the deficiencies, as the FDA then showed up AGAIN in, most recently in April 2017....leading to the much, much more SERIOUS FDA FORMAL, "WARNING LETTER", which ain't over by any stretch yet IMO.

https://www.fda.gov/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ORA/ORAElectronicReadingRoom/default.htm

Plug-in "Stem Cell" in the search bar and SHAZAM-O-WAMO, you get the U.S. Stem Cell Clinic/Comella FDA FORM 483 Observations and warnings.

AND, the real kicker to me...is thee FDA lists USSC as a "BIOLOGICAL DRUG MANUFACTURER" on title of "type of location inspected"....whoah daddy, gonna go from bad to worse here IMO. The WARNING LETTER essentially makes it PLAIN AS DAY TO ME, that the FDA is coming after USSC/Comella for "MANUFACTURING A NON FDA NEW DRUG" which of course would be a violation of numerous Federal laws...like major league...and then added numerous "other" violations of law observed by thee FDA, on top of that BIG ONE, the "illegal drug making" one...like that's not enough, LOL !!

https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-afda-orgs/documents/document/ucm572416.pdf

There it is, in all its glory.

Look at top of form:

TYPE OF ESTABLISHMENT INSPECTED:
BIOLOGICAL DRUG MANUFACTURER

They be in hot water if you ask me....this ain't gonna just "blow over", not a chance in H to me...not after these 483 warnings, AND THEN they got a FORMAL WARNING LETTER, COMPLETE WITH PERSONAL COMMENTS ADDED BY THEE FDA COMMISSIONER HIMSELF...rather scathing comments at that....it gonna get worse if you ask me, potentially much worse....

AND THEN...the "FORMAL WARNING LETTER" full txt itself...HOLY COW...

""VIA UPS NEXT DAY AIR
w/ DELIVERY CONFIRMATION

WARNING LETTER

OBPO 1 17-02

August 24, 2017

Ms. Kristin Comella
Chief Scientific Officer
US Stem Cell Clinic, LLC
12651 W. Sunrise Blvd., Suite 104
Sunrise, FL 33323

Dear Ms. Comella:

During an inspection of your firm, US Stem Cell Clinic, LLC (USSC)1 located at 12651 W. Sunrise Blvd., Suite 104, Sunrise, FL 33323, conducted between April 10 and May 11, 2017, the Food and Drug Administration (FDA) found that your firm recovers and processes adipose tissue, a structural tissue, from donors for autologous use. Your firm uses (b)(4) to (b)(4) components from adipose tissue, which are further processed into stromal vascular fraction (SVF). Your SVF product is generally administered intravenously or intrathecally for a variety of diseases or conditions.

Records gathered during the inspection reflect that your SVF product is intended to treat a variety of diseases and conditions, including, but not limited to, Parkinson’s disease, amyotrophic lateral sclerosis (ALS), chronic obstructive pulmonary disease (COPD), heart disease, and pulmonary fibrosis. In addition, on your website you claim to “offer stem cell treatments” for “neurological . . . autoimmune . . . degenerative” and other conditions, including but not limited to “Parkinson’s, ALS . . . Rheumatoid Arthritis, Crohn’s, Colitis, Lupus . . . COPD, Diabetes, [and] Congestive Heart Failure.” See usstemcellclinic.com.

Therefore, your SVF product is a drug under section 201(g) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) [21 U.S.C. 321(g)] and a biological product as defined in section 351(i) of the Public Health Service Act (PHS Act) [42 U.S.C. 262(i)].2 It is also a human cell, tissue, or cellular or tissue-based product (HCT/P) as defined in 21 CFR 1271.3(d). 3

Your SVF product does not meet all of the criteria in 21 CFR 1271.10(a), and therefore does not qualify for regulation solely under section 361 of the PHS Act [42 U.S.C. 264] and the regulations in 21 CFR Part 1271. Specifically, your SVF product does not meet the minimal manipulation criterion set forth in 21 CFR 1271.10(a)(1) and defined for structural tissue, such as adipose tissue, in 21 CFR 1271.3(f)(1). Your product does not meet this criterion because your processing alters the original relevant characteristics of the adipose tissue relating to the tissue’s utility for reconstruction, repair, or replacement.

In addition, your SVF product fails to meet the 21 CFR 1271.10(a) (2) criterion that the HCT/P be “intended for homologous use only, as reflected by the labeling, advertising, or other indications of the manufacturer’s objective intent.” As noted above, the SVF product is intended for use in the treatment of a variety of diseases or conditions. Because the SVF product is not intended to perform the same basic function or functions of adipose tissue, such as cushioning the body, using the SVF product for treatment of these diseases or conditions is not homologous use as defined in 21 CFR 1271.3(c). As a result, your SVF product does not qualify for regulation solely under section 361 of the PHS Act and 21 CFR Part 1271.

Please be advised that in order to lawfully market a drug that is a biological product, a valid biologics license must be in effect [21 U.S.C. 355(a); 42 U.S.C. 262(a)]. Such licenses are issued only after a showing of safety and efficacy for the product’s intended use. While in the development stage, such products may be used in humans only if the sponsor has an investigational new drug application (IND) in effect as specified by FDA regulations [21 U.S.C. 355(i); 21 CFR Part 312]. Your SVF product is not the subject of an approved biologics license application (BLA) (b)(4).

Additionally, during the inspection, FDA investigators documented evidence of significant deviations from current good manufacturing practice (CGMP) and current good tissue practice (CGTP) between December 8, 2015, and April 17, 2017, in the manufacture of at least (b)(4) lots of your SVF product. These deviations from CGMP and CGTP include deviations from section 501(a) (2) (B) of the FD&C Act, and 21 CFR Parts 210, 211, and 1271. Many of these deviations were the same or similar to the observations listed on the Form FDA 483 issued to you at the conclusion of FDA’s previous inspection of your firm between October 22 and December 7, 2015.

At the close of the April-May 2017 inspection, FDA investigators issued a list of inspectional observations (Form FDA 483), which described a number of significant objectionable conditions relating to your facility’s compliance with CGMP and CGTP. These include, but are not limited to the following:

1. Failure to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile, namely, your SVF product, including procedures for validation of all aseptic and sterilization processes [21 CFR 211.113(b)]. For example:

a. Your firm recovers adipose tissue and manufactures autologous SVF from this adipose tissue. During the period December 8, 2015 –April 17, 2017, your firm manufactured at least (b)(4) batches of SVF product. Your firm failed to validate and document your aseptic manufacturing process or to establish written procedures to prevent microbiological contamination of the SVF product. Your firm administers the SVF product by various methods, including intravenously and intrathecally. By the nature of its method of administration, the SVF product purports to be sterile and is expected to be sterile.

b. (b)(4) testing of the (b)(4) used in the manufacture of the SVF product is not performed.

c. On May 3, 2017, our investigators observed an accumulation of dust on two air vents in the room where the SVF product is manufactured.

d. Your firm failed to use disinfectant agents that are appropriate for use for cleaning the (b)(4), the (b)(4), and the (b)(4), which are located inside the aseptic processing area. For example, you use non-sterile (b)(4) and non-sterile wipes and do not use a sporicidal agent.

2. Failure to establish written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess [21 CFR 211.100(a)]. Specifically, you (b)(4) the (b)(4) components from adipose tissue through (b)(4) and (b)(4), which are further processed into your SVF product by (b)(4) and (b)(4). You have not validated the manufacturing process for your SVF product.

3. Failure to perform appropriate laboratory testing, as necessary, of each batch of drug product required to be free of objectionable microorganisms [21 CFR 211.165(b)]. Specifically, you failed to perform appropriate laboratory testing, including sterility and endotoxin testing, on at least (b)(4) batches of the SVF product manufactured between December 8, 2015, and April 17, 2017. Such laboratory testing is necessary for the SVF product, which by the nature of its method of administration is required to be free of objectionable microorganisms.

4. Failure to have an adequate system for monitoring environmental conditions in an aseptic processing area [21 CFR 211.42(c) (10) (iv)]. Specifically, your firm has not established an adequate system for environmental monitoring in the aseptic processing area where the SVF product is manufactured.

5. Failure to establish and follow written procedures for cleaning and maintenance of equipment [21 CFR 211.67(b)]. For example:

a. Your firm has not established any written procedures for cleaning or maintenance for the (b)(4), the (b)(4), or the (b)(4).

b. Your firm is using a (b)(4), manufactured by (b)(4) during the manufacture of the SVF product. This (b)(4) has not been certified or qualified for its intended use.

6. Failure to have a written record of major equipment cleaning, maintenance and use [21 CFR 211.182]. Specifically, your firm lacks records reflecting that cleaning, sanitizing, and inspections of equipment have been performed prior to, during, or after the manufacture of each batch of SVF product.

7. Failure to ensure that manufacturing personnel wear clean clothing appropriate for the duties they perform, including protective apparel, such as head, face, hand, and arm coverings, as necessary to protect drug products from contamination [21 CFR 211.28(a)]. Specifically, your firm failed to ensure that employees engaged in the processing of the SVF product wear clothing necessary to protect the drug from contamination. For example, non-sterile surgical masks and bouffant caps are worn during the processing of the SVF product.

8. Failure to maintain laboratory controls that include the establishment of scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure the components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality and purity [21 CFR 211.160(b)]. For example, you have not established procedures for testing the final SVF product, including tests for identity, strength, quality, and purity.

9. Failure to establish and follow written procedures describing in sufficient detail the receipt, identification, storage, handling, sampling, testing, and approval or rejection of components and drug product containers and closures [21 CFR 211.80(a)]. Specifically, you failed to establish and follow written acceptance criteria for components. You also failed to establish and follow written procedures for sampling, testing, or examining each lot of components received and released for use in the manufacture of at least (b)(4) batches of SVF product during the period December 8, 2015 and April 17, 2017. Components received and used by your firm to manufacture the SVF product include, but are not limited to, (b)(4), and (b)(4).

10. Failure to ensure that each lot of components, drug product containers, and closures are withheld from use until the lot has been sampled, tested, or examined, as appropriate, and released for use by the quality control unit [21 CFR 211.84(a)]. For example, the (b)(4) used in the manufacture of the SVF product is for research use only, as stated on the manufacturer’s product insert which was provided by your firm. Your firm lacks evidence, such as testing, to demonstrate this component meets all specifications of identity, strength, quality, and purity.

11. Failure to establish a quality control unit that has the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material, labeling, and drug products, and the authority to review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated [21 CFR 211.22(a)].

12. Failure to prepare batch production and control records for each batch of drug product produced with complete information relating to the production and control of each batch. These records shall include documentation that each significant step in the manufacture, processing, packing, or holding of the batch was accomplished [21 CFR 211.188(b)]. For example, you did not document each significant step in the manufacture, processing, packing, or holding of each batch of your SVF product, including the identify of each batch of component or in-process material used and all persons performing each significant step.

13. Failure to establish and follow written procedures describing the handling of all written and oral complaints regarding a drug product [21 CFR 211.198(a)]. Specifically, your firm has not established written procedures for handling complaints, including procedures to determine whether an investigation is needed.

14. Failure to prominently label the SVF product as “for autologous use only” and “not evaluated for infectious substances.” [21 CFR 1271.90(c) (1) and (2)].

The FDA investigators also documented that you impaired their ability to conduct the April-May 2017 inspection. For example, you delayed the inspection by refusing to allow entry except by appointment only and denied the investigators access to your employees. Please be aware that it is a prohibited act to refuse to permit entry or inspection as authorized by section 704 of the FD&C Act [21 U.S.C. 374]. See 21 U.S.C. 331(f). In addition, under section 501(j) of the FD&C Act, 21 U.S.C. 351(j), when an owner, operator, or agent delays, denies, limits, or refuses an inspection, the drugs may be deemed adulterated. See FDA Guidance, Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection, available at www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM360484.pdf.

Review of Inspectional Response

We acknowledge receipt of your written response, dated May 16, 2017, and note that it did not address any of the observations identified on the Form FDA 483. Instead, you claim, among other things, that you are not required to comply with the requirements of 21 CFR Part 1271, because your firm qualifies for the same surgical procedure exception at 21 CFR 1271.15(b). The same surgical procedure exception applies to an establishment that removes HCT/Ps from an individual and implants “such HCT/Ps” into the same individual during the same surgical procedure. Among other things, the HCT/Ps your firm removes from individuals (adipose tissue) plainly are not the HCT/Ps that are used (SVF) following processing by various means (e.g., (b)(4) or (b)(4)). Therefore, your firm does not qualify for the same surgical procedure exception.

You also claim that your product is exempt from regulation “because the procedures practiced at USSC do not involve more than ‘minimal manipulation.’” As detailed above, your product does not meet this criterion set forth in 21 CFR 1271.10(a) (1), because your processing alters the original relevant characteristics of the adipose tissue relating to the tissue’s utility for reconstruction, repair, or replacement.

You further state that your firm’s manufacture of the SVF product falls within the practice of medicine and beyond FDA’s jurisdictional reach. As explained, your SVF product is a drug as defined in section 201(g) of the FD&C Act and a biological product as defined in section 351(i) of the PHS Act. FDA is charged with enforcing the FD&C Act as it applies to FDA-regulated articles such as your SVF product.

Neither this letter nor the observations noted on the Form FDA 483, which were discussed with you at the conclusion of the inspection, are intended to be an all-inclusive list of deficiencies that may exist at your facility. It is your responsibility as management to ensure that your firm is in compliance with the FD&C Act, PHS Act, and all applicable regulations.

You should take prompt action to correct these deviations. Failure to promptly correct these deviations may result in regulatory action without further notice. Such actions include seizure and/or injunction.

Further information about IND requirements for biological products may be obtained through the Division of Regulatory Project Management, Office of Tissues and Advanced Therapies, at [phone] or [e-mail]. Please include a copy of this letter with your initial submission to CBER.

Please notify this office in writing, within 15 working days of receipt of this letter, of any steps you have taken or will take to correct the noted deviations and to prevent their recurrence. Include any documentation necessary to show that correction has been achieved. If you do not believe your product is in violation of the FD&C Act, PHS Act, or applicable regulations, include your reasoning and any supporting information for our consideration. If corrective actions cannot be completed within 15 working days, state the reason for the delay and the time within which all corrections will be completed.

Your response should be sent to the U.S. Food and Drug Administration, Florida District Office, 555 Winderley Place, Suite 200, Maitland, FL 32751, or emailed to [e-mail] . If you have any questions regarding this letter, please contact Mr. Randall L. Morris, Compliance Officer at [phone].


Sincerely,
/s/
Elizabeth A. Waltrip
Program Division Director, Acting

cc: U.S. Stem Cell, Inc.
13794 NW 4th Street
Suite 212
Sunrise, Florida 33325



1 US Stem Cell Clinic, LLC is a subsidiary of US Stem Cell, Inc., which was formerly known as Bioheart, Inc.
2 The definition of “drug” includes “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man.” 21 U.S.C. 321(g). The term “biological product” means “a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein (except any chemically synthesized polypeptide), or analogous product, or arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of a disease or condition of human beings.” 42 U.S.C. 262(i) (1).

3 HCT/Ps are defined as “articles containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient.” 21 CFR 1271.3(d).

US Stem Cell Clinic, LLC 8/24/17"

HOLY FREAKING COW.....this is serious, serious stuff. B A D, BAD. This kind of "ENFORCEMENT ACTION" can put people out of biz, PERMANENTLY many times. Seizure..INJUNCTION...who knows what... It's big, big league ball now....FDA ain't messin around looks like to me....

HOLY, HOLY COW....AND THEN, THE FDA REJECTED Comella's first "RESPONSES"...good gawd...they told her, "NOPE, NOTHING YOU SAID ADDRESSES THE MULTIPLE 483 WARNING/INSPECTIONS WE ISSUED, nor were any properly "addressed/resolved" via your "response" (it’s all in the formal WARNING LETTER, stating the FDA did not “Accept” Comella’s responses and in fact sent investigators BACK TO THE CLINIC as recent as April 2017 that we know of.....WOWZA.....SCATHING....

USCC/Comella MULTIPLE FDA 483 WARNINGS !

Was wondering where the FORM 483's were. I'd checked the FDA site where they post 483's, and had not found any for USRM/Comella/USSC in the past...but shazam, it's there now.

One of them 483 warnings is now up on the FDA's public website. AND, it shows/states that the clinic was inspected by the FDA much earlier, 12/7/2015 and received FDA 483 WARNING THEN, to which they obviously did not properly respond, nor heed, nor correct the deficiencies, as the FDA then showed up AGAIN in, most recently in April 2017....leading to the much, much more SERIOUS FDA FORMAL, "WARNING LETTER", which ain't over by any stretch yet IMO.

https://www.fda.gov/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ORA/ORAElectronicReadingRoom/default.htm

Plug-in "Stem Cell" in the search bar and SHAZAM-O-WAMO, you get the U.S. Stem Cell Clinic/Comella FDA FORM 483 Observations and warnings.

AND, the real kicker to me...is thee FDA lists USSC as a "BIOLOGICAL DRUG MANUFACTURER" on title of "type of location inspected"....whoah daddy, gonna go from bad to worse here IMO. The WARNING LETTER essentially makes it PLAIN AS DAY TO ME, that the FDA is coming after USSC/Comella for "MANUFACTURING A NON FDA NEW DRUG" which of course would be a violation of numerous Federal laws...like major league...and then added numerous "other" violations of law observed by thee FDA, on top of that BIG ONE, the "illegal drug making" one...like that's not enough, LOL !!

https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-afda-orgs/documents/document/ucm572416.pdf

There it is, in all its glory.

Look at top of form:

TYPE OF ESTABLISHMENT INSPECTED:
BIOLOGICAL DRUG MANUFACTURER

They be in hot water if you ask me....this ain't gonna just "blow over", not a chance in H to me...not after these 483 warnings, AND THEN they got a FORMAL WARNING LETTER, COMPLETE WITH PERSONAL COMMENTS ADDED BY THEE FDA COMMISSIONER HIMSELF...rather scathing comments at that....it gonna get worse if you ask me, potentially much worse....

That was the actual 483, now dig the FDA "REJECTING Comella's response...MIND BLOWING to me.....

FDA ALREADY REJECTED Comella FIRST RESPONSE !

READ THE FDA "WARNING LETTER" very carefully and one will see that thee FDA "REJECTED" Comella's first attempt(s) at DENIAL and "WE DO NOTHING WRONG" to the FDA, in response to the 483's being issued. THUS, the FDA "WARNING LETTER", typically thee last step before the FDA takes serious, high level legal action(s).

So what does Comella do??? SHE ISSUES ANOTHER RESPONSE full of DENY, DENY, DENY and YOU THE FDA are supposedly "WRONG, WRONG WRONG blah, blah, blah.. might as well just PAINT THE TARGET ON YOUR BACK to make it that much easier- even though they have a laser marker on you and radar lock combined, LOL !! Gonna be the easiest target they ever took out IMO.

FROM THE FDA WARNING LETTER, SHOWING THEY'VE ALREADY REJECTED Comella's FIRST DENIAL/RESPONSE to the FORM 483's, which is what GOT THE WARNING LETTER SENT, for failing to follow the FDA's warnings and instructions:


Quote:

Review of Inspectional Response

We acknowledge receipt of your written response, dated May 16, 2017, and note that it did not address any of the observations identified on the Form FDA 483. Instead, you claim, among other things, that you are not required to comply with the requirements of 21 CFR Part 1271, because your firm qualifies for the same surgical procedure exception at 21 CFR 1271.15(b). The same surgical procedure exception applies to an establishment that removes HCT/Ps from an individual and implants “such HCT/Ps” into the same individual during the same surgical procedure. Among other things, the HCT/Ps your firm removes from individuals (adipose tissue) plainly are not the HCT/Ps that are used (SVF) following processing by various means (e.g., (b)(4) or (b)(4)). Therefore, your firm does not qualify for the same surgical procedure exception.

You also claim that your product is exempt from regulation “because the procedures practiced at USSC do not involve more than ‘minimal manipulation.’” As detailed above, your product does not meet this criterion set forth in 21 CFR 1271.10(a) (1), because your processing alters the original relevant characteristics of the adipose tissue relating to the tissue’s utility for reconstruction, repair, or replacement.

You further state that your firm’s manufacture of the SVF product falls within the practice of medicine and beyond FDA’s jurisdictional reach. As explained, your SVF product is a drug as defined in section 201(g) of the FD&C Act and a biological product as defined in section 351(i) of the PHS Act. FDA is charged with enforcing the FD&C Act as it applies to FDA-regulated articles such as your SVF product.

Neither this letter nor the observations noted on the Form FDA 483, which were discussed with you at the conclusion of the inspection, are intended to be an all-inclusive list of deficiencies that may exist at your facility. It is your responsibility as management to ensure that your firm is in compliance with the FD&C Act, PHS Act, and all applicable regulations.

You should take prompt action to correct these deviations. Failure to promptly correct these deviations may result in regulatory action without further notice. Such actions include seizure and/or injunction."

END QUOTE..

NOTICE THAT: SHE, Comella, SHE EARNED THEM A "WARNING LETTER" post the 483 warnings, for failing to heed the FDA's first attempts to tell her/USRM to, "STOP VIOLATING FDA LAWS". But she, Comella, she responded to the first 483 inspection WARNINGS just like she did now to the "WARNING LETTER" trying to use DENIAL and ARGUE with the FDA, and the FDA told her (probably laughing at the response it was so bad IMO) TOLD HER, NOPE, WRONG, YOU'RE MAKING A DRUG, WE TOLD YOU THAT ALREADY and your freaking "response" DID NOT ADDRESS/CORRECT A SINGLE ITEM WE WARNED YOU ABOUT.

So congratulations, you just got a "WARNING LETTER" now, the FDA Commissioner is now personally following this, and you made the FDA "PR" page and now negative WORLD WIDE NEWS.

BRILLIANT. Really, really freaking smart, LOL.

So what's she do? SHE DOUBLES DOWN AGAIN, making the lame Youtube "response" and then writing a lame, hastily prepared "written response" and sends it right back to the FDA, with DENY, DENY, DENY and WE DON'T DO ANYTHING WRONG and blah, blah, blah......

FDA is probably gonna put this one down in the history books or HOW TO FAIL AT A FDA RESPONSE to a serious "WARNING LETTER" if you ask me....I thought it might be Comedy Central or something at first....but NOPER...it's the real deal. DENIAL, not just a river in Egypt.

Next up....when does the FDA DROP THE HAMMER, the big gun stuff, the 500 and 1000 pounders.....the U.S. attorneys or the injunctions or seizures or whatever they plan to do.....gonna hit um harder than freaking Irma if you ask me.....a wrecking ball is coming their way...and it's the FEDERAL GOVERNMENT...with enormous budgets and almost unlimited resources....and USRM had about $900K cash left last qtr, w/ about $1.4 MILLION in just "accounts payable" (an INCREASE over last qtr, looks like they ain't paying them bill due very fast..uh..uh..???) and around $6 MILLION IN TOTAL "CURRENT LIABILITIES"....they're gonna get bulldozed if you ask me....just common sense to me....

The "WARNING LETTER" is just the start now if you ask me...it only GETS WORSE FROM HERE IMO... much, much worse potentially.....

HOLY FREAKING COW....SEVERAL "rounds" of FDA 483 "WARNINGS" then it got escalated to a "FORMAL WARNING LETTER" and it's still an open issue...NO "close out" issued, AND the FDA Commissioner himself made PERSONAL ADDED COMMENTARY not only in the FDA formal "PRESS RELEASE" but to public news outlets such as TIME mag, etc. WOWZA...freaking B A D, BAD if you ask me....stunning info to me......

http://time.com/4920259/fda-crackdown-stem-cell-clinics/

https://www.washingtonpost.com/news/to-your-health/wp/2017/08/28/fda-cracks-down-on-stem-cell-clinics-including-one-using-smallpox-vaccine-in-cancer-patients/?utm_term=.4b4de70b83f5

https://www.washingtonpost.com/news/to-your-health/wp/2017/03/15/three-women-blinded-by-unapproved-stem-cell-treatment-at-south-florida-clinic/?utm_term=.589b8e3d7552

http://www.aarp.org/health/conditions-treatments/info-2017/fda-monitoring-stem-cell-clinics.html

https://www.reuters.com/article/us-fda-regenerative-medicine-idUSKCN1B81KP

http://floridanationalnews.com/blog/fda-commissioner-to-crack-down-on-dangerous-stem-cell-clinics/

http://www.philly.com/philly/health/fda-moves-to-curb-dangerous-stem-cell-clinics-20170828.html

http://www.latimes.com/science/sciencenow/la-sci-sn-fda-stem-cells-20170828-story.html

http://www.npr.org/sections/health-shots/2017/08/28/546719842/fda-cracks-down-on-stem-cell-clinics-selling-unapproved-treatments

https://www.bloomberg.com/news/articles/2017-08-28/fda-raids-one-stem-cell-lab-and-warns-another-in-regulatory-push

http://www.dailymail.co.uk/health/article-4830734/FDA-seizes-dangerous-unapproved-vaccine.html

DAILY MAIL....that makes the UK...GLOBAL NEWS....

https://www.truthinadvertising.org/u-s-stem-cell-clinic/

https://www.regenexx.com/fda-crackdown-stem-cell-wildwest/

http://blogs.discovermagazine.com/d-brief/2017/08/29/immunotherapy-fda-raid/

https://medworm.com/400766395/fda-moves-against-unproven-treatments-at-stem-cell-centers/

http://www.biopharminternational.com/fda-commissioner-issues-statement-new-stem-cell-therapy-and-regenerative-meds-policy

https://www.newsmax.com/Health/Health-News/stem-cell-regulation-fda/2017/08/28/id/810205/

https://www.accesswire.com/473913/US-Stem-Cell-Clinic-Acknowledges-Warning-Letter-By-The-FDA-and-Responds

https://www.statnews.com/2017/08/28/smallpox-stem-cell-clinic/

http://www.webmd.com/a-to-z-guides/news/20170828/fda-serious-problems-at-florida-stem-cell-clinic

http://ktla.com/2017/08/28/fda-to-crack-down-on-stem-cell-clinics-after-unapproved-vaccine-is-used-at-rancho-mirage-and-beverly-hills-clinics/

http://www.sun-sentinel.com/health/fl-fea-fda-cites-florida-stem-cell-clinic-20170828-story.html

https://www.upi.com/Health_News/2017/08/28/FDA-moves-against-unproven-treatments-at-stem-cell-centers/3981503935433/

https://www.cnbc.com/2017/08/28/reuters-america-update-1-u-s-fda-steps-up-scrutiny-of-stem-cell-therapies.html

http://www.chicagotribune.com/lifestyles/health/ct-fda-cracks-down-on-stem-cell-clinics-offering-risky-treatments-20170828-story.html

https://www.reuters.com/article/us-fda-regenerative-medicine-idUSKCN1B81KP

http://www.cnn.com/2017/08/28/health/fda-stem-cells-bn/index.html

https://www.medpagetoday.com/publichealthpolicy/stemcellresearch/67555

http://www.kyma.com/lifestyle/technology/fda-cracks-down-on-stem-cell-clinics/613510555

http://gearsofbiz.com/fda-cracks-down-on-clinics-selling-unproven-stem-cell-therapies/40779

http://www.medscape.com/viewarticle/884855

http://www.nasdaq.com/press-release/us-stem-cell-clinic-acknowledges-warning-letter-by-the-fda-and-responds-20170828-00703

http://m.startribune.com/fda-to-crack-down-on-unscrupulous-stem-cell-clinics/442061853/?section=%2F

https://www.managedcaremag.com/news/fda-step-regulation-stem-cell-therapies-regenerative-medicine

https://www.visionaware.org/blog/visionaware-blog/the-fda-officially-cracks-down-on-stem-cell-clinics-offering-unproven-and-dangerous-treatments/12

https://www.arcamax.com/currentnews/newsheadlines/s-1991994

http://newburghgazette.com/2017/08/28/fda-issues-warning-letter-to-us-stem-cell-clinic-for/

http://www.the-scientist.com/?articles.view/articleNo/50219/title/FDA-Goes-After-Two-Stem-Cell-Clinics/

http://www.empr.com/news/stem-cell-therapies-policy-regulation-fda-vaccinia-seizure/article/684724/

https://www.caredash.com/news/healthcare/shady-stem-cell-clinics-under-fda-investigation

http://www.biopharminternational.com/fda-commissioner-issues-statement-new-stem-cell-therapy-and-regenerative-meds-policy

https://www.law360.com/articles/958173

http://news.xinhuanet.com/english/2017-08/29/c_136563166.htm

CHINA...NEWS BREAKING WORLD WIDE..uh oh....BAD....

http://rock947.com/news/articles/2017/aug/28/fda-steps-up-scrutiny-of-regenerative-medicine/

http://www.startribune.com/fda-to-crack-down-on-unscrupulous-stem-cell-clinics/442061853/

https://ww2.kqed.org/futureofyou/2017/08/28/feds-seize-smallpox-vaccine-as-fda-targets-deceitful-stem-cell-clinics/

http://www.drugdeliverybusiness.com/fda-intervenes-stem-cell-center-offers-unproven-treatment-cancer-patients/

https://www.labroots.com/trending/cancer/6767/fda-takes-action-unscrupulous-stem-cell-clinics

http://vothemes.com/2017/08/fda-serious-problems-at-florida-stem-cell-clinic/

https://www.doctorslounge.com/index.php/news/pb/74727

http://www.beckershospitalreview.com/supply-chain/fda-cracks-down-on-stem-cell-clinics-offering-unapproved-treatments.html

http://www.baystreet.ca/viewarticle.aspx?id=473913

http://www.pulseheadlines.com/fda-cracks-clinics-unapproved-steam-cell-treatments/66513/

http://scienceblogs.com/insolence/2017/09/01/whats-scarier-than-dubious-stem-cell-clinics-naturopathic-stem-cell-clinics/

http://www.rightinginjustice.com/news/2017/09/01/stem-cell-treatment-center-warned-by-fda/

LAW FIRM BLOG…..the lawsuits are next IMO….LOL…watch the lawyers come out of the woodwork looking for damaged patients…..they can smell the money on this one IMO…

http://ktla.com/2017/08/28/fda-to-crack-down-on-stem-cell-clinics-after-unapproved-vaccine-is-used-at-rancho-mirage-and-beverly-hills-clinics/

THAT IS B A D, BAD coverage, LOL !!! NOT the way you want your company to "get known", at least not IMO.

I think the lawyers are gonna come out of the woodwork on this now...like sharks in a bloody pool of chum....they can smell it probably....and CASH POOR USRM is gonna be in a legal battle that'll probably bury um...in my humble opinion... I think this is just the start...the tip of a bad iceberg....and a mess that's busting wide, wide open...an onion about to get peeled back.....

WONDER NOW WHY GACP "TERMINATED" their supposed "$5 million investment agreement"....LOL???? LOOK AT THE DATES ON THAT DEAL GONE BAD, and the FDA WARNING DOCUMENTS...gee...another SHAZAM moment for good ole USRM/Bioheart....never a let down in the drama department....LOL !!