US Stem Cell Inc (USRM)

[Dragon Lady]

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, which is what GOT THE WARNING LETTER SENT, for failing to follow the FDA's warnings and instructions:

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

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."

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 $1.2 MILLION in just accounts payable and around $6 MILLION IN CURRENT LIABILITIES...which is now just about their lousy market cap....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.....