Sun Pharma Draws Warning Letter for Multiple Quality Problems

Indian generics company Sun Pharmaceutical Industries took another hit from the FDA, receiving an FDA warning letter after the company failed to adequately address the agency’s concerns over lapses in aseptic procedures, inadequate media fills, poorly designed and ventilated cleanrooms, and flaws in vial-filling machinery.

In December, the agency placed most of the products shipped from the company’s Halol facility on import alert until Sun complies with current Good Manufacturing Practice standards, the agency said.

The new warning letter cited several problems related to an investigation of a November 2021 media fill failure, “which revealed serious flaws and risks” in the operation. Sun was also dinged for faulty cleanroom designs that could result in contamination of active pharmaceutical ingredients.

The company must submit a corrective and preventive action plan to implement routine, vigilant operations management oversight (corporate and local) of facilities and equipment, the FDA said.