FDA 483 - Cipla, Ltd. - November 30, 2018

Cipla, Ltd., a drug and API manufacturer in Kurkumbh Village, India, was inspected by the FDA from November 26-30, 2018. The inspection resulted in an FDA Form 483, detailing significant observations related to their manufacturing operations and adherence to good manufacturing practices. Key issues included a failure to adequately follow written procedures for equipment cleaning and maintenance. Specifically, the firm lacked sufficient cleaning validation data for shared manufacturing equipment, especially for hard-to-clean areas and demonstrating complete removal of cleaning detergents after use.

Further observations highlighted deficiencies in following written production and process control procedures. Cipla, Ltd. failed to provide raw data evidence for critical manufacturing process parameters, such as blend values, for exhibit batches, relying instead on manual calculations without proper verifiable records. Training records for operators involved in these critical calculations were also found to be inadequate. Additionally, the inspection revealed a lack of raw data for 100% fill weight checks during packing operations and insufficient verification for in-process fill weight checks and equipment setup. Critical packaging machine setup parameters, including fill weight tolerances, lacked secondary verification.

These findings suggest a need for improved data integrity and stricter adherence to established protocols to ensure product quality and safety. Cipla, Ltd. is expected to provide a comprehensive response with corrective and preventive actions to address these deficiencies and achieve compliance with regulatory standards.