FDA warns Wyeth about Puerto Rico plant

4 June 2006

The US Food and Drug Administration has sent a letter to pharmaceutical major Wyeth, warning of Good Manufacturing Practices violations at its Puerto Rico facility, reports the Associated Press.

The FDA conducted its inspection of the firm's facility in Guayama between November and December 2005, and found oversights in manufacture, processing, packing and holding of the human drug products made there, including the contraceptive Triphasil-21 (levonorgestrel and ethinyl estradiol).

As well as warning of the violations themselves, the agency has reprimanded Wyeth for its slow response to its concerns, noting that lots of affected drugs are still in circulation.

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