Sun Pharmaceutical Industries is back on track with the FDA regarding its Cranbury, NJ, manufacturing plant. Results of a June re-inspection found the plant had "an acceptable regulatory status."
The re-inspection follows an Aug. 25, 2010, warning letter that included GMP violations for its inability to produce drug batches of consistent quality and for a lack of detail in the fixes it was proposing to the FDA.
Sun is not out of the regulatory woods yet, however. In Detroit, Sun subsidiary Caraco continues to work with consultants to resolve the manufacturing shortcomings. It's been operating under a consent decree with the FDA since 2009. GMP violations eventually led to seizure of 33 medications by U.S. Marshals and the subsequent shutdown of plants in plants in Detroit, Farmington Hills and Wixom, MI.
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