FDA Orders Seizure of Drugs From Michigan Pharmaceutical Facilities
Today the U.S. Marshals responded to a directive from the Food and Drug Administration (FDA) ordering the seizure of drugs from Caraco Pharmaceutical Laboratories, Ltd.'s facilities in Detroit, Farmington Hills and Wixom. Caraco Labs, which apparently manufacturers over 60 varieties of generic pharmaceuticals, is alleged to have failed to comply with the FDA's mandatory current Good Manufacturing Practice (cGMP) regulations, which ensure drug quality. The specific violations named involve manufacturing defects, including oversized tablets and possible formulation error. The U.S. Marshals also seized ingredients held at the same facility.
Caraco Labs previously issued major drug recalls in January 2009 in an attempt to recapture the defective medications. An FDA inspection completed in May of 2009 uncovered continuing cGMP standard violations. The drastic action taken during today's seizure will hopefully lead to major changes at Caraco's facilities.
The FDA's cGMP standards are designed to ensure that drugs are manufactured, handled, and repackaged correctly, and include strict requirements to ensure that unsafe pharmaceuticals are not introduced into commerce. The standards require drugmakers to obtain and use raw materials of appropriate quality, maintain reliable testing labs, eliminate cross-contamination with beta-lactam drugs, etc.
