FDA 483 - Lupin Limited - September 20, 2019

During an inspection conducted from September 16-20, 2019, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Lupin Limited, an API manufacturer located in Tarapur, Thane, Maharashtra, India. The inspection highlighted significant concerns regarding the company's adherence to good manufacturing practices, specifically in areas of quality control, record-keeping, and facility cleanliness. The primary violations included a failure to thoroughly investigate unexplained discrepancies, such as metal particle contamination in API batches. The investigation was found deficient as it did not extend to all potentially affected products manufactured using the same equipment, and no metal detection was performed prior to the release of these batches for the U.S. market. Additionally, damage to equipment was not properly assessed for risk to other API batches, and incidents were not documented in batch records or equipment logs. Further observations noted that batch production and control records lacked complete information. Manufacturing operators were found to be making critical process changes without proper guidance in batch records or approval from the Quality Department, with such changes not being documented in executed batch records. Lastly, the inspection revealed inadequate handling and storage of cleaned utensils, which were found co-located with "to be cleaned" drums in an emergency exit corridor. An umbrella was also observed in an equipment cleaning room, raising concerns about potential cross-contamination. Lupin Limited is required to promptly address these observations by conducting comprehensive investigations, implementing robust corrective and preventive actions, and ensuring all manufacturing processes, documentation, and facility controls comply with established good manufacturing practices to safeguard product quality and patient safety.