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FDA Concerned About Wyeth Manufacturing Standards

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At a glance:

The FDA is concerned about Wyeth's manufacturing processes at a factory in Puerto Rico. 
 
In a letter to Wyeth, the FDA mentioned violations in packaging, inspection, reporting, and following up on contamination evidence, which allegedly were observed during an inspection last winter. 
 
Drugs involved are reported to be Triphasil, Prempro, Effexor, and Advil. 
 
The company claims there is no danger to the public, and it is working on the problems, but the FDA claims it is taking too long. 
 

FDA sends Wyeth a warning letter

BusinessWeek - 5/30/2006 5:42 PM

MAY. 30 5:36 P.M. ET The Food and Drug Administration sent Wyeth a warning letter about violations of good manufacturing practices at a plant in Puerto Rico.
 
The letter, which regulators posted on the agency's Web site Tuesday, said there were problems in the manufacture of several drugs, including birth control pill Triphasil, hormone replacement Prempro, antidepressant Effexor and over-the-counter pa
 
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