FDA 483 - Aarti Drugs Limited - September 20, 2024

Aarti Drugs Limited, an API manufacturer in Tarapur, India, was cited for significant deficiencies across its quality systems during an FDA inspection. The firm demonstrated inadequate procedures for investigating deviations and OOS results, scientifically unsound test methods, and a lack of stability-indicating test procedures for API expiry dating. Furthermore, the inspection revealed issues with cleaning validation, ineffective quality unit oversight, and insufficient internal audit processes, compounded by missing API distribution records.