FDA WARNING_LETTER - Sandoz Private Limited - August 29, 2014

The FDA inspected Sandoz Private Limited's Kalwe and Turbhe pharmaceutical manufacturing facilities in August 2014, identifying significant violations of current Good Manufacturing Practice (CGMP) regulations (21 CFR Parts 210 and 211), rendering drug products adulterated. At the Kalwe facility, violations included failure to maintain contemporaneous batch production records, inadequate equipment maintenance records, insufficient personnel training and falsified training records, failure to thoroughly investigate out-of-specification results and withholding information from the FDA, and lack of appropriate controls over computer systems to prevent data tampering. At the Turbhe facility, violations related to aseptic process controls, specifically failure to establish and follow procedures to prevent microbiological contamination, including inadequate unidirectional airflow studies and failure to establish procedures for removing units after interventions. Additionally, the firm failed to establish an adequate environmental monitoring system for aseptic areas. These deficiencies demonstrate a critical failure in the firm's quality system, particularly concerning data integrity. The FDA strongly recommended hiring a third-party auditor. Sandoz must provide a comprehensive investigation, risk assessment, and a detailed global corrective and preventive action plan within 15 working days. Failure to correct these violations may result in the FDA withholding approval of new applications and refusing admission of products manufactured at both facilities into the United States.