FDA seizure intended to drive "major changes" at Caraco

Continued violations of good manufacturing practices have led to the seizure of 33 medications and drug ingredients at plants in Michigan, the FDA says. U.S. Marshals last week visited generic drug maker Caraco Pharmaceutical facilities in Detroit, Farmington Hills and Wixom for the seizure, following a May 2009 inspection, October 31, 2008, FDA warning letter, and company-initiated recalls.

Oversized tablets, poor control of its raw materials, and a possible formulation error prompted the action. The May inspection yielded unresolved violations of cGMP requirements. "Today's seizure is intended to lead to major changes at Caraco's facilities," the FDA says in an announcement.

A Caraco announcement counters that the company believes corrective actions have been made and continual improvements are in process. "While we have not fully determined the impact of this action by the FDA on our financial condition, we believe that it may have a material adverse effect on our near term operations," the announcement says.

The company also says it anticipates working with the FDA to resolve concerns "as effectively and expeditiously as possible."

- read the FDA announcement
- here's an FDA Q&A with additional detail
- see the Caraco release

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