Two Michigan plants that three years ago had so many manufacturing and recall problems that the FDA felt compelled to send in U.S. marshals to lock up products have been given permission to again manufacture some drugs, Sun Pharmaceutical Industries said today.
Although a closeout letter has yet to be posted on the FDA website, the public company announced that the FDA has cleared the two Caraco subsidiary plants in Detroit and nearby Wixom. Initially, they can manufacture only two products, heart drug Carvedilol and antibiotic Paromomycin.
Even then, "Caraco is required to now work with an external auditor conducting regular inspections for an extended period," the Indian drugmaker said. The company made no mention of a packaging plant in Farmington Hills that also had been visited by marshals in 2009.
The company said production of these products and any pending approval that might be added will be gradual as the company submits to a "rigorous approval procedure" so revenue also will be added incrementally.
The seizure of about $20 million worth of products three years ago and the issuance of a consent decree was tied to a string of issues. Caraco had to recall metformin pills for diabetes that fell on both sides of the size specification and were contaminated with metal scrapings, a 2008 warning letter said. The FDA said Caraco had poor control of its raw materials and a possible formulation error. "Today's seizure is intended to lead to major changes at Caraco's facilities," the FDA said at the time. The company today says those major changes have taken place.
- here's the announcement
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