FDA 483 - Concord Biotech Limited - May 02, 2025

An FDA inspection of Concord Biotech Limited in Dholka Ahmedabad, India, revealed significant deficiencies in manufacturing practices for Active Pharmaceutical Ingredients (API). Observations included inadequate equipment cleaning, insufficient laboratory controls for microbiological testing verification, and poor data integrity controls for computerized systems. Additionally, the firm failed to properly monitor and control water quality used in API manufacturing steps.