Quote LOL NO, "FDA needs to answer the questions!
"
WHAT???? LOL ??? The FDA doesn't have to "ANSWER" a damn thing, LOL !!
The FDA doesn't send WARNING LETTERS after numerous attempts at failed 483 responses and "other" failures to respond to them, so that YOU, YOU can try and "debate" them, LOL !!
The freaking FDA PR contained personal commentary by thee, thee newly named DIRECTOR OF THEE FDA, Gottlieb, that is how "high up" this train wreck goes.
The FDA didn't, and DOES NOT send ole, "HEY, LETS DEBATE THE LAW, 100 FREE QUESTIONS LETTERS", LOL !!
It's thee FDA WHO ASKS THE QUESTIONS, they don't have to "answer" a damn thing to pimple USRM, or Comella or the LLC "clinic" biz or anyone else.
The FDA, IMO, is gonna PULL THE DOUBLE FLUSH HANDLE on those freaking lame questions. The FDA COULD CARE LESS, at some abstinent wash-list of bogus demands and questions being fired-back at them, LOL!!!
When you get pulled over, when you break the law, etc- YOU, YOU do not get to "DEBATE THE LAW" with the law enforcement officer. In FACT, when you pull that kind of nonsense, most law enforcement dudes I know, they might just decide to tack-on a few more charges, just for pissing um off, after they tried to be decent and reasonably nice to you, LOL!!
Comella and USRM, they ain't winning any FDA points with the stupid question list/DEMANDS, IMO. FDA is gonna ignore it all, all of it, if you ask me. Won't even acknowledge it- just gonna state as they did already, "YOU FAILED TO ADDRESS A SINGLE ACTIONABLE ITEM WITH A CREDIBLE RESPONSE AS TO YOUR DETAILED CORRECTIVE ACTION PLAN" and then .....see you at the "next level", which IMO, will be a FDA or U.S. attorney "meet n greet" letter or something to that effect, if not an outright injunction or similar.
My guess, the FDA is just about DONE dealing with the abstinent, screw-you attitude that USRM and Comella seem to exude against the FDA. LAWS and LAW ENFORCEMENT IS NOT UP FOR FREAKING "DEBATE", not how it works in this nation. Ignorance of the law is not even a viable defense.
The stupid, "WELL, OTHER CLINICS DO THIS, SO YOU CAN'T JUST PICK US" blah, blah BS is 100% the lamest thing I've ever heard.
MILLIONS of people speed each day- but do every one of them get a speeding ticket? NO. DRUG DEALERS ARE EVERYWHERE, but do all get busted? NO.
LAW ENFORCEMENT PICKS THEIR BATTLES where they can apply resources and pick the ones they feel are important etc and THAT IS THEIR BUSINESS and NO EXCUSE TO "GET OFF THE HOOK" just cause you, your business happened to get lucky, get picked for a SPANK DOWN.
Totally lame response IMO, just beyond the pale that a supposed professional would try that as some sort of "defense" or way out of the FDA's WARNINGS, and what's likely now to follow....just lame...lame...lame...to me....
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