US Stem Cell Inc (USRM)

[Dragon Lady]

Quote LOL, "According to the fda web site, a warning letter is used to gain voluntary compliance. "

Uh....they had MULTIPLE 483 WARNINGS THEY DID NOT HEED/CORRECT, going back to at least Dec 2015...that's how they GOT THE WARNING LETTER. It's IN THE DAMN LETTER ITSELF, explained in great detail. Also, the original 483 WARNING is now on the FDA public portal.

Look at the clinic website- Comella still claims to "treat" pretty much every serious malady known to mankind, such as ALS, MS, Parkinson's, Spinal cord issues, neurological and on and on and on, all via "SVF" (fat derived, NO HOMOLOGOUS according to newly issued GUIDANCE DOCS) and thus she's using a NON FDA APPROVED NEW DRUG which she actually "manufactures" ON HER PREMISES (with cGMP violations to boot, MORE SERIOUS), a very serious allegation, about as bad as it gets.

W/O a IND in place for every single one of those conditions AND prior FDA approval(s) to run legit trials on such maladies, Comella CAN NOT BE "IN COMPLIANCE"...thus, an WARNING LETTER states very, very, very, very, very CLEARLY that WITHOUT FURTHER NOTICE NEEDING TO BE GIVEN, thee FDA/Federal Govt, typically with assistance of the U.S. Attorney branch can, "TAKE FURTHER ENFORCEMENT ACTIONS SUCH AS SEIZURE, INJUNCTION and even CRIMINAL ACTIONS" and it says so right in the damn warning letter, including listing every "condition" they "claim" to treat with "SVF" which the FDA says CLEAR AS CRYSTAL is a "NON FDA APPROVED NEW DRUG" (uh, ILLEGAL, HELLO???) and it also states, "THE CONDITIONS YOU CLAIM TO TREAT HAVE NO FDA APPROVALS AND THEREFOR WHAT YOU'RE DOING IS ILLEGAL", as is using an NON FDA NEW DRUG, cGMP violations which the FDA takes EXTREEEEEMELY seriously, and then also states Comella attempted to, and/or may still be "impeding an FDA inspection/investigation", also stated to be a Federal crime, etc

Not sure if you've ever worked in any FDA regulated companies/situations?

WARNING LETTERS put the fear of the almighty in "most" Sr Mgt and often get companies shut down. It's THEE LAST STEP before using court orders and "other" means against a company/individuals.

THEE FDA COMMISSIONER HIMSELF in the PR and other media outlets labeled USCC/Comella as "UNSCRUPULOUS" and as "BAD ACTORS" and stated he's created a special "TASK FORCE/WORKING GROUP" to "USE EVERY LEGAL MEANS NECESSARY" to shut down such operations...he said it, it's public info. It was in the FDA's FORMAL PR that accompanied the WARNING LETTER ENFORCEMENT ACTION sent to USCC/Comella and the San Diego firm they busted on the same day's PR.

Comella is not out begging for LEGAL DEFENSE FUND MONIES cause things are all swell and peachy, LOL !