U.S. Marshals, at the request of the U.S. Food and Drug Administration (FDA), seized drug products manufactured by Caraco Pharmaceutical Laboratories Limited. The products were seized at Caraco’s Michigan facilities in Detroit, Farmington Hills, and Wixom and also include ingredients held at these 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,” she added, said the FDA.

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 Caraco complies with cGMP requirements.

Caraco has initiated voluntary recalls of drug products since January 2009 that involved manufacturing defects, including oversized tablets and possible formulation errors. For instance, This past March we wrote that Caraco Pharmaceuticals issued a recall of several lots of Digoxin tablets it had made. In May we wrote about another recall, also issued because there was a chance that the Digoxin tablets involved differed in size and therefore could contain too much or too little of the drug’s active ingredient.

Late last year we also wrote that Caraco Pharmaceuticals received an FDA warning letter because of conditions at its Detroit plant. At that time, the FDA was withholding all future marketing approvals for medicines manufactured at the plant until the problems cited in the letter were corrected. That letter followed an inspection held at Caraco’s Detroit facility, which was initiated in May 2008. The problems cited in the warning letter included the inadequate and untimely investigation of certain incidents by the quality control unit at the facility contrary to the company’s standard operating procedures. The FDA considered some of the observations to be repeat observations.

The FDA has now determined that the seizure of Caraco’s drugs may create a shortage of one product, choline magnesium trisalicylate oral tablets, which are commonly used as pain relievers. The FDA recommends in the event of a shortage, that health care providers consider alternative treatments that are safe and effective. Consumers and health care providers who are unable to obtain any of Caraco’s products should contact the FDA Drug Shortage Program by e-mail at drugshortages@fda.hhs.gov, or by telephone at 888-463-6332 or 301-796-3400.

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, said the FDA.

If the FDA identifies further significant problems, which pose risks to patient safety with any Caraco drug products on the market, the agency will take appropriate additional regulatory action and immediately notify the public. “The FDA will continue to take swift, aggressive enforcement action when firms are identified as being in violation of our manufacturing requirements,” said Michael Chappell, FDA acting associate commissioner for regulatory affairs. Seizure of drug products is an effective remedy when there is evidence of continued poor compliance with cGMPs.

This entry was posted on Friday, June 26th, 2009 at 9:04 am and is filed under Pharmaceuticals.