FDA 483 - Maiva Pharma Private Limited - October 29, 2022

During an inspection from October 20-29, 2022, the FDA identified significant manufacturing deficiencies at Maiva Pharma Private Limited, a sterile drug manufacturer in Hosur, Tamil Nadu, India. The inspection report, known as an FDA 483, highlighted critical issues primarily related to data integrity, environmental control, and aseptic processing validation, indicating non-conformance with Good Manufacturing Practices.

Key violations included inadequate control over computerized systems, such as missing data backups, the use of shared passwords for critical equipment, and a lack of validation for an upgraded HPLC system. Environmental monitoring in aseptic areas was found deficient, with issues like unvalidated cleaning processes, unmonitored particle counts in critical zones, air leaks into sterile areas, mold growth, and improper personnel gowning. Furthermore, the validation of aseptic processes was inadequate, lacking proper incubation records for media fills and failing to account for potential contamination sources from personnel entry procedures. Batch records also lacked proper identification of individuals performing critical manufacturing steps. Finally, airflow visualization studies crucial for sterile operations were incomplete, failing to cover all interventions and critical equipment dynamically.

Maiva Pharma is required to provide a comprehensive response detailing corrective and preventive actions to address these observations, ensuring future compliance and the integrity of their sterile manufacturing processes.