FDA 483 - Eugia SEZ Private Limited - March 01, 2019

An FDA inspection of Aurobindo Pharma Limited's sterile drug product manufacturing facility in Mahabubnagar District, India, conducted from February 22 to March 1, 2019, revealed eleven significant deviations from current Good Manufacturing Practices (CGMP). Key issues highlighted included a deficient Quality Control Unit, failing to adequately assess manufacturing processes and ensure product quality. The firm demonstrated inadequate control procedures, evidenced by numerous particulate complaints in sterile injectable products, with investigations often failing to identify root causes. There was a consistent failure to thoroughly review unexplained discrepancies, such as vial integrity issues leading to leakage and assay results at the lower end of specifications.

Further observations noted inadequate employee training for visual inspection, specifically regarding comprehensive techniques and defect identification. Aseptic processing areas exhibited critical deficiencies in environmental monitoring, including unjustified particle counter locations and smoke studies that did not accurately represent dynamic interventions. Procedures to prevent microbiological contamination were not adequately established or followed, with process simulations failing to reflect routine operations. Laboratory controls were also found deficient, lacking scientifically sound specifications, statistically justified sampling plans, and proper investigation of out-of-trend results. Data integrity concerns were raised due to inadequate computer system controls allowing unauthorized changes to analytical methods.

Additionally, the firm lacked robust procedures for component sampling and testing, failing to adequately evaluate or disqualify API suppliers after receiving contaminated materials that led to product recalls. Incomplete records for incoming raw material samples were noted, and critical test methods were unverified or outdated. Aurobindo Pharma Limited is required to address these observations comprehensively to ensure full compliance with CGMP regulations for sterile drug product manufacturing.