FDA WARNING_LETTER - Claris Injectables Limited - August 04, 2017

The FDA inspected Claris Injectables Ltd. in Ahmedabad, India, from July 27 to August 4, 2017, identifying significant violations of current Good Manufacturing Practice (CGMP) regulations (21 CFR parts 210 and 211), rendering drug products adulterated. Key deficiencies included the firm's failure to thoroughly investigate out-of-specification (OOS) results and batch failures (21 CFR 211.192), leading to product recalls. The firm also failed to prepare complete batch production and control records (21 CFR 211.188), with observed non-contemporaneous data entry. Additionally, the facility was not maintained in a good state of repair (21 CFR 211.58), showing extensive water damage. Overall, the quality system demonstrated inadequate data integrity. The firm's responses were deemed insufficient, lacking comprehensive root cause analyses and effective corrective and preventive actions (CAPA). The FDA noted a history of similar CGMP violations and recurring product defects, particularly concerning container-closure systems. The agency strongly recommended engaging a qualified consultant and requested a regulatory meeting with Baxter, which acquired the facility on the inspection start date. Claris Injectables Ltd. must provide detailed retrospective reviews of OOS investigations, remediated procedures, and comprehensive assessments of container-closure materials and suppliers. Failure to correct these violations may result in withheld approvals for new applications, refusal of product admission into the U.S., and potential drug shortages. A written response detailing corrective actions is required within 15 working days.