FDA 483 - Asphar Research Labs Private Limited - July 17, 2024

The FDA inspection of Asphar Research Labs Private Limited in Hyderabad, India, identified significant deficiencies within its quality control unit. The firm failed to consistently follow written procedures for assay testing, adequately investigate equipment defects such as moisture ingress in stability chambers, and ensure proper traceability for stability sample management. These issues collectively indicate a lack of robust quality oversight essential for ensuring the consistent quality of drug products.