FDA 483 - Harman Finochem Limited - March 18, 2024

An FDA inspection of Harman Finochem Ltd. in Aurangabad, India, revealed deficiencies in laboratory controls. Specifically, the firm's methods for microbiological analysis of water used in non-sterile active pharmaceutical ingredient production were not scientifically sound, lacking proper validation and justification for testing procedures. This indicates a significant concern regarding the quality assurance of raw materials.