Quote, "curious about this one. Does the FDA have a duty to publicly announce when a company has been cleared? "
While an investigation is still open (they took reams and mountains of data from Comella at the clinic - paper copies, computer file copies, photos, etc) NO, like any law enforcement/regulatory "action/agency" the FDA will discuss nothing about it to the public, as long as it is on-going, which can be a year or more easily in a major investigation.
Secondly, the FDA formal "WARNING LETTER LETTER" makes it crystal clear- that once you are issued a "FORMAL WARNING LETTER", the Federal Govt and the FDA need "GIVE NO MORE NOTICE TO YOU" before taking additional "enforcement actions" and they spell out such "actions" which ban be seizure (come and take product or items from your business) or "injunction" which will be a court ordered action to "cease doing business" or something like that, or even "criminal prosecution" for failing to comply with the "WARNING LETTER", such as Comella continuing to operate the clinic and still advertising on the website "claiming" she will "treat" such conditions as COPD, Parkinson's, ALS and a plethora of others FOR CASH, all specific medical "conditions/maladies" which the "WARNING LETTER" listed in detail by name- and said "YOU ARE PEDDLING AN ILLEGAL NON FDA APPROVED NEW DRUG" (w/o a IND or Biologics license so NO WAY is Comella suddenly somehow "in compliance" LOL !) and also "YOU ARE CLAIMING TO TREAT CONDITIONS USING SVF FAT DERIVED STEM CELLS THAT HAVE NO KNOWN OR PROVEN SCIENTIFIC EFFICACY AND NO FDA APPROVALS FOR A SINGLE INDICATION YOU CLAIM TO TREAT"...just go read the FDA "WARNING LETTER" and associated FDA FORMAL PRESS RELEASE...it's all spelled-out in GREAT, GREAT DETAIL...and they claim the clinic/Comella "TRIED TO IMPEDE A FEDERAL INVESTIGATION", which is a potential Federal crime AND they then also cited the clinic/Comella for numerous cGMP violations which the FDA takes extremely serious for anyone even remotely familiar with FDA practices/enforcement actions....AND they also cited numerous codified sections of the Federal FDA LAW and noted which one Comella/The clinic were violating (The Food, Drug and Cosmetic Act laws) and that list was long......
NOTHING is "over" or "taken care of" or "CLOSED OUT" just cause Comella blathered on some self-made Youtube video and wrote a ltr that didn't address a SINGLE ISSUE THE FDA RAISED IN THE WARNING LTR, let alone a detailed "corrective action plan" which is how one responds to WARNING LETTERS, usually via a very experienced "REGULATORY COMPLIANCE PERSON" and even usually a FDA "compliance legal counsel", as it can get companies put out of business and people fined and even arrested, etc
There's some "STEM CELL WARNING LETTERS" and you'll see the Comella/USCC letter listed, and in the "CLOSE OUT" column, ZIPPO....it's wide open...NOTHING has "been handled" or is "over" IMO....totally false to make such claims....looks like a open, on-going FDA investigation to me...and the Federal govt ain't known for "moving fast"...again, MONTHS and MONTHS and even a year may pass before they "file charges" or issue an "injunction" etc.
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