FDA 483 - Maiva Pharma Private Limited - February 10, 2026

An FDA inspection of Maiva Pharma Private Limited, a sterile drug manufacturer, from February 10-20, 2026, revealed significant deviations from Good Manufacturing Practices. Key observations in the FDA Form 483 document include critical data integrity failures, with numerous original manufacturing and control records found discarded and not properly reconciled. The inspection identified substantial deficiencies in aseptic processing and environmental control, such as media fill simulations that do not reflect routine operations, inadequate investigations into microbial excursions, and insufficient environmental monitoring during critical interventions and pre-assembly activities. Furthermore, the firm failed to thoroughly investigate various discrepancies, including out-of-specification results and customer complaints, often lacking supporting documentation or scientific justification for root cause determinations. Laboratory controls were compromised by improper testing techniques, and the Quality Unit exhibited a lack of independent oversight in document destruction and inadequate visual inspection qualification. These findings highlight a need for comprehensive corrective and preventive actions to ensure product quality, safety, and regulatory compliance.