U.S. Marshals Seize Drug Products Manufactured by Caraco Pharmaceutical (CPD); FDA Acts to Prevent Repeated Drug Quality Problems

June 25, 2009 3:59 PM EDT

U.S. Marshals, at the request of the FDA, today seized drug products manufactured by Caraco Pharmaceuticals (Amex: CPD), at the company’s Michigan facilities in Detroit, Farmington Hills, and Wixom. The seizure also includes ingredients held at these same facilities.

“The FDA is committed to taking enforcement action against firms that do not manufacture drugs in accordance with our good manufacturing practice requirements,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “Compliance with these standards prevents harm to the public.”

This action follows Caraco’s continued failure to meet the FDA’s current Good Manufacturing Practice (cGMP) requirements, which assure the quality of manufactured drugs. Through this seizure, the FDA seeks to immediately stop the firm from further distributing drugs until there is assurance that the firm complies with good manufacturing requirements.

Since January 2009, Caraco has initiated voluntary recalls of drug products to protect the public from potentially defective medications. The recalls involved manufacturing defects, including oversized tablets and possible formulation error.

The FDA’s most recent inspection of Caraco, completed in May 2009, found unresolved violations of cGMP requirements. Today’s seizure is intended to lead to major changes at Caraco’s facilities.

Caraco Pharmaceutical Laboratories, Ltd. (Caraco) is engaged in the business of developing, manufacturing, marketing and distributing generic and private-label pharmaceuticals to wholesalers, distributors, warehousing and non-warehousing chain drugstores and managed care providers, throughout the United States and Puerto Rico.[SM]

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