Wyeth - Pharma manufacturing consent decrees

Start Date: 2000
Financial penalties: $297 million plus 18.5% of sales
End Date: still pending

This case involves GMP violations at plants in Pennsylvania and New York that were producing FluShield. FDA inspectors identified the issues during plant visits that date back to 1995. Because the flu vaccine was considered a medical necessity, the FDA permitted its manufacture at a noncompliant location but assessed the percentage-of-sales penalty. The product was ultimately discontinued and Wyeth closed two plants.

Wyeth - Pharma manufacturing consent decrees