Wednesday, July 21, 2010

Details Emerge From Latest Merck -- J&J FDA "483" Letter

UPDATED -- 07.22.10 @ 9 AM EDT -- Here is the full-text FDA 483 report (in PDF format), courtesy of Pharmalot -- and, it's a doozy!

We first mentioned this over the weekend, but now -- per Reuters reporting, this afternoon -- the details are trickling out:

. . . .U.S. government inspectors found problems with test procedures, record-keeping and handling of consumer complaints at a Johnson & Johnson and Merck & Co. manufacturing plant in Pennsylvania, a report released on Wednesday said.

The Food and Drug Administration listed 12 shortcomings uncovered by agency inspectors who visited the Lancaster, Pennsylvania, site in late June and early July. . . .

As ever, more to come -- but Merck is off about $0.60, on pretty solid volume, on the NYSE on the news.


Anonymous said...

So, while not specifically mentioning Zetia, I think this article is relevant to your postings;

Anonymous said...

and credit to Pharmalot as well