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FDA sends Wyeth a warning letter

May 30, 2006 | AP

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 pain reliever Advil.

Among the violations noted in the May 3 letter from the FDA is the failure to clean and maintain packaging equipment to prevent contamination, plus not adequately inspecting packaging and labeling machines before use to insure all previous products had been removed.


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