FDA 483 - Alivira Animal Health Limited - September 18, 2023

An FDA inspection of Alvira Animal Health Limited, an Active Pharmaceutical Ingredient Manufacturer in Visakhapatnam, India, revealed a significant issue regarding quality control. The firm failed to adequately document and review critical in-process and laboratory test results within their Batch Manufacturing Records for API finished products. This indicates a potential systemic problem with data integrity and quality assurance processes.