FDA 483 - Chemspec Chemicals Private Limited - August 01, 2025

An FDA inspection of Chemspec Chemicals Private Limited, an API manufacturer in Navi Mumbai, India, revealed significant deficiencies across multiple areas. The firm failed to maintain adequate batch records, control document issuance, ensure proper quality unit oversight, validate test procedures for raw materials, conduct thorough investigations, and contemporaneously record quality-related activities. Additionally, cleaning procedures and their documentation were found to be deficient.