FDA 483 - ZYDUS LIFESCIENCES LIMITED - May 03, 2019

During an inspection from April 22 to May 3, 2019, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Cadila Healthcare Limited in Ahmedabad, Gujarat, India. The inspection of this drug manufacturing facility uncovered significant deviations from Good Manufacturing Practices (GMP) regulations. Key issues included inadequate cleaning and maintenance of manufacturing equipment, with observable residues on supposedly clean surfaces and damaged components. Deficiencies were noted in procedures to prevent microbiological contamination of sterile drug products, citing improper personnel conduct in aseptic areas and insufficient validation of aseptic processes. The facility's environmental control systems also showed major shortcomings, such as issues with filtered air supply, inadequate monitoring, and incomplete HVAC system documentation that could lead to cross-contamination. Additionally, the inspection highlighted a lack of robust data integrity practices, with insufficient backup and trending of critical process data. The company failed to thoroughly investigate unexplained discrepancies, including sterilization cycle failures and consumer complaints about product odor, without proper analytical testing or root cause analysis. Production and process controls were found lacking, impacting product identity, strength, quality, and purity. Cadila Healthcare Limited is expected to implement comprehensive corrective and preventive actions to address these GMP violations.