U.S. Marshals, acting at the request of the Food and Drug Administration (FDA), have seized drug products manufactured by Caraco Pharmaceutical Laboratories Ltd., 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."
The move follows Caraco's continued failure to meet the FDA's current Good Manufacturing Practice requirements, which assure the quality of manufactured drugs, the agency said.
Through this seizure, the FDA said it seeks to put an immediate halt to the firm's further distribution of drugs until there is assurance that it 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 said it has 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 agency recommends in the event of a shortage, that health care providers consider alternative treatments that are safe and effective.
The FDA's most recent inspection of Caraco, completed in May 2009, found unresolved violations of cGMP requirements. This seizure is intended to lead to major changes at Caraco’s facilities, the agency said in a statement.
If the FDA identifies further significant problems, which pose risks to patient safety with any Caraco drug products on the market, it 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.
Source: consumeraffairs.com
