FDA 483 - Apitoria Pharma Private Limited - September 27, 2024

This FDA Form 483 was issued to Apitoria Pharma Private Limited, an API (Active Pharmaceutical Ingredient) manufacturer located in Sanga Reddy District, Telangana, India, following an inspection from September 23-27, 2024. The report, issued to Sridhar Smat, Associate Vice President Operations, details ten observations related to manufacturing and quality control deficiencies.

Key observations include: 1. **Equipment Upkeep:** Manufacturing equipment showed visible scratch marks, dents, and white residue/stains on product-contact surfaces, indicating inadequate cleaning and maintenance. Preventive maintenance checklists did not include checks for these issues. 2. **Manufacturing Instructions:** Production records lacked adequate manufacturing instructions, specifically regarding visual checks by operators and the inclusion of variable parameters for equipment operation. Cleaning records for product change-over and periodic cleaning did not include instructions or documentation for visual inspection checks. 3. **Training Deficiencies:** Personnel were not adequately trained on swab sampling for cleaning verification or on assessing microbial growth in growth promotion tests. 4. **Quality Unit Review:** The quality unit failed to adequately review and approve quality-related documents, specifically a change control for a reduced batch size API, leading to discrepancies in batch record checklists. 5. **Water System and Sampling:** The water system design was inadequate, with an unprotected open-environment tank for solution preparation. Water sampling demonstrations showed improper technique, including contamination risks and leaking connectors. 6