FDA 483 - Aurobindo Pharma Limited - January 28, 2026

An FDA inspection of Aurobindo Pharma Limited, Unit VII, a finished drug product manufacturer in India, was conducted from January 28 to February 10, 2026. The inspection resulted in nine significant observations detailed in an FDA 483 document, highlighting serious deficiencies in adhering to current good manufacturing practices. Primary violations included critical issues within the facility and equipment. Non-dedicated manufacturing equipment, particularly HEPA filters and ducts, were not adequately cleaned for years, leading to significant drug substance cross-contamination (exceeding acceptable limits by up to 545 times) and extensive microbial contamination, including pathogenic bacteria. The company"s preventative maintenance program and Quality Unit oversight for cleaning were found deficient, compounded by instances of personnel providing untruthful statements regarding cleaning practices. Deficiencies in the production system involved inadequate control over computer systems, such as shared login credentials, unauthorized file deletion capabilities, and the overwriting of essential electronic test reports without proper backup procedures. Master production records lacked complete manufacturing instructions and sufficient documentation for sampling. The Quality System demonstrated substantial failures, including inadequate complaint investigations (e.g., missing risk assessments, durability testing, and follow-up). The firm failed to thoroughly investigate discrepancies, keeping drug product batches with borderline impurity levels in the U.S. market and delaying critical stability studies. Oversight of testing data integrity was compromised, with potential falsification of sample collection data and deviations from aseptic techniques. Additionally, compliance with employee training on manufacturing practices was severely lacking, with numerous pending training documents. Laboratory control systems showed deficiencies in record-keeping, including instances of backdated documents and inconsistencies between recorded and electronic data. Established laboratory procedures, such as appearance testing and microbiology plate reading, were not consistently followed. Aurobindo Pharma Limited must thoroughly investigate these observations and implement comprehensive, sustainable corrective and preventive actions to ensure full compliance with regulatory requirements for drug manufacturing.