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.
This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.
Login to your accountTry before you buy
7 day trial access
Become a subscriber
Or £77 per month
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed
Chairman, Sanofi Aventis UK
Copyright © The Pharma Letter 2025 | Headless Content Management with Blaze