FDA acts to prevent repeated drug quality problemsYesterday, U.S. Marshals, at the request of the Food and Drug Administration, seized drug products manufactured by Caraco Pharmaceutical Laboratories Ltd. (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 repeated violations of FDA’s current Good Manufacturing Practice (cGMP) 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. FDA’s seizure is intended to lead to major changes at Caraco’s facilities.
The FDA 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 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. Following a drug product seizure, companies often agree to a wide range of changes and improvements to their drug manufacturing practices at their facilities.
To View the entire FDA press release visit: www.fda.gov.
To view the listing of products affected by this recall visit: www.fda.gov.
This action follows repeated violations of FDA’s current Good Manufacturing Practice (cGMP) 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. FDA’s seizure is intended to lead to major changes at Caraco’s facilities.
The FDA 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 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. Following a drug product seizure, companies often agree to a wide range of changes and improvements to their drug manufacturing practices at their facilities.
To View the entire FDA press release visit: www.fda.gov.
To view the listing of products affected by this recall visit: www.fda.gov.
Posts
No comments:
Post a Comment