Caraco - Pharma manufacturing consent decrees

Start Date: 2009
Financial penalties: none
End Date: still pending

Unresolved GMP violations in Caraco's Michigan facilities prompted a visit by U.S. Marshalls, who seized 33 medications and drug ingredients at plants in Detroit, Farmington Hills and Wixom.

The product seizures followed a series of drug recalls stemming from manufacturing defects. Contamination figures prominently in a warning letter issued to the company in October 2008, as do shortcomings in the procedures used after its discovery.

Caraco was forced to cease manufacturing at the sites, and to hire a consultant to oversee the operations overhaul.

Caraco - Pharma manufacturing consent decrees