FDA 483 - Vamsi Labs Ltd - April 18, 2025

An FDA inspection of Vamsi Labs Ltd, an API manufacturer in Solapur North, Maharashtra, India, revealed significant deficiencies in data integrity, quality unit responsibilities, laboratory controls, and validation practices. Findings included unsigned batch records, inadequate API testing, poorly investigated deviations in computerized systems, and undefined quality unit roles with concerning data access privileges. Additionally, the firm failed to document departures from procedures, properly tag out-of-calibration equipment, and conduct transport validation studies for APIs shipped to the US.