FDA Slaps Intas with Warning Letter

The India-based cancer drug manufacturer is accused of quality control violations and data destruction.

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According to a recent BioSpace article, the FDA issued a warning letter to Intas Pharmaceuticals, a cancer drug manufacturer based in India, due to several quality control issues at its Sanand plant. The violations include significant breaches of current good manufacturing practice (CGMP) and destruction of data. In November 2022, an Intas analyst was observed pouring acetic acid into a trash bin containing CGMP records, and a quality control officer witnessed the same analyst destroying data sheets. Another analyst admitted to not reporting all of the results after weighing out amitriptyline hydrochloride tablets multiple times, and FDA investigators found plastic bags full of discarded CGMP documents across the manufacturing facilities. Intas had been previously notified of these infractions but has not fully met the FDA's requirements to rectify the issues.