FDA seizes 33 drugs from Michigan generics plant
In a rare move, the FDA seized shipments of 33 generic drugs from three Michigan manufacturing plants that failed to pass inspections following a 2008 warning letter from the agency. Federal marshals took action after Caraco Pharmaceutical Laboratories failed to make improvements identified in an FDA inspection earlier this year as a part of its current Good Manufacturing Practice requirements.
“The FDA will continue to take swift, aggressive enforcement action when firms are identified as being in violation of our manufacturing requirements,” FDA acting associate commissioner for regulatory affairs Michael Chapell said in a statement.
Caraco has voluntarily recalled other drugs in 2009, including the heart medication digoxin, which inspectors found to be variable in size, and thus may have contained the wrong amount of active ingredient.
Congress is considering how to better safeguard the drug supply chain after a rash of U.S. deaths in 2008 were linked to contaminated heparin that originated in China, and recent GAO reports indicate that the agency lacks significant resources to conduct regular inspections of all manufacturing sites that contribute to the U.S. pharmaceuticals market.
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