U.S. Marshals, at the request of the Food and drug Adminstration , seized drug products manufactured at Caraco Pharmaceutical laboratories limited (Caraco), at the company’s Michigan facilities in Detroit, Farmington Hills, and Wixom. The seizure also includes ingredients held at these same facilities.
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, FDA again found unresolved violations of cGMP requirements. Now this seizure is intended to lead to major changes at Caraco’s facilities.
Now all the pharmaceutical industries intended to sell their product in US, must be aware that their manufacturing facilities should be in compliance with cGMP. As FDA is committed to taking enforcement action against firms that do not manufacture drugs in accordance with our good manufacturing practice requirements, said by Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.
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 considered to be an effective remedy when there is evidence of continued poor compliance with cGMPs. Following a drug product seizure, companies often agree to a wide range of changes and improvements to their drug manufacturing practices at their facilities.
But such drug seizure may create a shortage of the drug product seized. In case of Caraco's drugs FDA has determined that the seizure of Caraco's drugs may create a shortage of one product, magnesium trisalicylate oral tablets, which are commonly used as pain relievers. So FDA recommends in the event of a shortage, 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.
