‘Similar’ Intas CGMP Violations

A 5/1-5/12 FDA inspection at the Intas Pharmaceuticals drug manufacturing facility in Matoda-Sanand, Ahmedabad, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs, many of which were similar to those from an earlier inspection. An 11/21 Warning Letter says specific violations were:

• failure of the quality control unit to exercise its responsibility to ensure drug products manufactured comply with CGMP and meet established specifications for identity, strength, quality, and purity;
• failing to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed;
• failing to establish adequate written procedures for production and process controls designed to assure that drug products have the identity, strength, purity, and quality that they are purported or represented to possess; and
• failing to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, including validation of all aseptic and sterilization processes.

The letter says the Intas quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs it manufactures. FDA acknowledges the company is using a consultant to audit its operation and assist in meeting agency requirements.

“In a previous inspection, including the inspection of 7/22-8/2/2019, FDA cited similar CGMP observations,” the letter says. “You proposed specific remediations for these observations in your responses. Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate.”

FDA further says that significant findings in the letter demonstrate that Intas does not operate an effective quality system in accord with CGMP. “In addition to the lack of effective production and laboratory operations oversight, we found your quality unit is not enabled to exercise proper authority and/or has insufficiently implemented its responsibilities. Executive management should immediately and comprehensively assess your company’s global manufacturing operations to ensure that your systems, processes, and products conform to FDA requirements.”

The agency placed Intas on an Import Alert on 11/14. The company was told to promptly correct the violations and to respond with a list of specific actions it has taken to correct the violations and prevent their recurrence, with a schedule for completing the corrections. Intas also is to schedule a regulatory meeting.