InvestorsHub Logo
icon url

jerseygirl

12/04/08 6:08 PM

#176661 RE: SSKILLZ1 #176659

CPD: Based on what I read on Motley and without doing further reasearch, the FDA warning has something to do with their manufacturing. I worked for a GMP/FDA regulated company for 8 years. Usually these issues are cleared up pretty quickly. It could be something that has to do with documentation or quality control. As long as they correct it, which they will do, they should be fine.

The issues are the time period for which the FDA will respond back or reinspect and how serious the infraction was.
icon url

Rawnoc

12/04/08 10:45 PM

#176663 RE: SSKILLZ1 #176659

Sometimes SKILLZ gives a bash post, and it actually makes sense. FDA warning letter? Okay, scratching CPD off the list. Once the FDA is on your ass in the generic drug biz.....good night. They drag their feet on drug approvals as it is. Warning that the quality control issue could delay approvals = they may be porked. And this may lead to recalls, certainly loss of customers with so many generic drug companies to choose from, why buy from one with FDA issues? ABRX learned that the hard way.