CGMP Violations at Baxter India Facility

A 1/19-1/27 FDA inspection at the Baxter Pharmaceuticals India drug manufacturing facility in Ahmedabad, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 7/25 Warning Letter says specific violations were:

• 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 had already been distributed;
• failing to establish and follow adequate written procedures for cleaning and maintaining equipment;
• failing to establish adequate written procedures for production and process control designed to assure that drug products the company manufactures have the identity, strength, quality, and purity they purport or are represented to possess, and to follow all of the written production and process control procedures; and
• failing to use equipment in the manufacturing, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and its cleaning and maintenance.

The letter says the significant inspection findings indicate the facility does not operate an effective quality system in accord with CGMP. FDA says it also found that the firm’s 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,” FDA says.

The letter further says the firm does not have an adequate ongoing program for monitoring process control to ensure stable manufacturing operations and consistent drug quality. It recommends that based on the nature of the violations found and the company’s failure to correct repeat violations, Baxter retain a qualified consultant to assist it in meeting CGMP requirements.

Baxter’s responses to the inspection observations were inadequate, FDA says.

The company was told to correct any violations promptly and to respond with a list of specific actions it has taken to address violations and prevent their recurrence, with a schedule for completing the corrections.