U.S. takes over three Tylenol plants

[cavegal]

http://money.cnn.com/2011/03/10/news/companies/johnson_mcneil_fda_action/index.htm

NEW YORK (CNNMoney) -- The government is taking over three Tylenol plants following a blizzard of drug recalls and a Food and Drug Administration criminal investigation into safety issues at the factories.

The FDA and the Justice Department on Thursday took action against McNeil PPC and two of its executives -- its vice president of quality and its vice president of operations for over-the-counter products -- for failing to comply with federally-mandated manufacturing practice

I post here feel free to move.. Even thought it is for supervision, the government never gives anything up.

[FreeBorn]

Hmmm... What sort of pharmaceutical interests exist in Hungarian portfolios these days?

[Chris]

Looks like a public safety issue to me. 

Moving to a more appropriate area.

[Eupher]

These days in the pharma world, a 483 (list of inspection observations by FDA inspectors) is pretty much a kiss of death. If you're a Director or above in Quality or Operations, you're toast.

ON the face of it, though, a consent decree is still pretty mild action. Of course, had McNeil not agreed to the consent decree, FDA would have moved forward with its lawsuit and most likely would've been found guilty of noncompliance to 21CFR Parts 210 and 211, aka the "Good Manufacturing Practices" regulations.

This will cost J&J big bucks. Consent decrees are hideously expensive, plus the requirement to bring on third party consultants to review the corrective actions and most likely, batch records prior to release, also ain't cheap.

FDA is empowered to conduct seizures and, if they have a mind to, to proceed forward on a criminal basis against individuals - it's pretty rare, but it has happened.

[cavegal]

Looks like a public safety issue to me. 

Moving to a more appropriate area.

Thank you ..