FDA Slams Piramal API plant with 483 for problems in quality control, equipment cleaning

A year after an FDA reprimand at its Michigan manufacturing plant, Indian drugmaker Piramal Pharma faces scrutiny again following an inspection of its Maharashtra, India, facility from February 11 to 17. The FDA issued a six-observation 483, citing deficiencies in quality control, record-keeping, equipment maintenance, and more.

The FDA criticized Piramal’s quality control unit for lacking written and fully followed procedures. During the inspection, agency officials observed a leak from equipment, with liquid pooling on the floor in an unattended room. Piramal’s site head suggested the operator was likely at lunch, but no documentation confirmed the operator’s activity or presence.

Further issues included inadequate follow-up on active pharmaceutical ingredient (API) batch deviations. In March 2024, four manufacturing deviations were reported, but Piramal failed to document a quality risk assessment to evaluate the viability of additional API batches, the FDA noted.

The FDA also flagged incomplete investigations into customer complaints. After a customer reported foreign particles in an API batch, Piramal tested samples from a different batch for potential contaminants but neglected to test the customer’s sample or retention samples from the affected batch.

Equipment maintenance was another concern, with the FDA noting that Piramal’s cleaning procedures for shared equipment—used to produce APIs for the U.S. and global markets—lacked validation. Additionally, the agency found fault with Piramal’s material storage practices, stating that components, key starting materials, API containers, and closures were not handled or stored to prevent contamination or ensure drug potency.

This latest FDA rebuke follows a Form 483 issued last February at Piramal’s Riverview, Michigan, API facility. That report, classified as “voluntary action indicated,” signaled objectionable conditions without prompting immediate regulatory action. Piramal stated then that the observations were unrelated to data integrity and promised a detailed response.