FDA 483 - Lupin Limited - November 10, 2025

An FDA inspection conducted at Lupin Limited from November 10-21, 2025, revealed significant deficiencies in the firm"s compliance with manufacturing and quality control standards. The inspection highlighted seven primary observations, indicating systemic issues across various operational areas. A key concern was the Quality Unit"s failure to manage drug products exceeding regulatory Acceptable Intake limits for impurities, leading to the continued market release of non-compliant batches, particularly Capsules USP. Investigations for these critical quality failures were inadequate, and Health Hazard Assessments were not performed promptly. The inspection also identified severe problems with analytical method reliability, where impurity testing for products like Capsules USP showed inconsistent and highly variable results without adequate investigation or scientific justification. Furthermore, the company deviated from its own procedures by not performing cleaning validation for impurities on shared manufacturing equipment, despite identified risks of cross-contamination. Significant lapses in investigating product discrepancies were noted, including inadequate Out-of-Specification investigations for dissolution failures, failure to submit Field Alert Reports to the FDA, and insufficient follow-up on compromised raw materials. Complaint handling was also deficient, with a failure to thoroughly investigate adverse drug events and product quality complaints, often due to a lack of complete information or proper sample collection. Finally, laboratory controls were found lacking, with unreliable swab sample analytical procedures potentially masking contamination, and an absence of formal procedures for "Non-routine Protocols" and "Miscellaneous samples," leading to uncontrolled testing. These observations collectively indicate a failure to ensure drug product safety, identity, strength, quality, and purity, necessitating comprehensive corrective and preventive actions to bring the facility into compliance with current Good Manufacturing Practices.