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

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to Chemspec Chemicals Private Limited following an inspection of their Navi Mumbai facility from July 28 to August 1, 2025. The letter details significant deviations from Current Good Manufacturing Practice (CGMP) for active pharmaceutical ingredients (APIs), rendering their products adulterated under the Federal Food, Drug, and Cosmetic Act.

Key violations primarily revolved around severe quality unit failures and pervasive data integrity issues. The company's quality unit failed to ensure API compliance with CGMP, lacked adequate control over critical documentation, and did not ensure employee adherence to data integrity principles. Specific examples include manufacturing and releasing API lots without complete batch manufacturing records, distributing products without quality unit review, and maintaining inconsistent lot numbering systems. Furthermore, the quality unit was found to have replaced original CGMP documents without investigation and allowed production operators to retroactively complete batch records, compromising data reliability.

The FDA deemed the company's August 21, 2025, response inadequate, noting insufficient reconciliation of missing records, lack of a comprehensive retrospective evaluation, and an incomplete plan to improve document controls. Chemspec Chemicals is required to provide a comprehensive assessment and remediation plan to empower its quality unit, ensuring robust procedures, effective oversight, and thorough batch review. Additionally, a complete assessment of all documentation systems and a detailed corrective and preventive action plan are mandated to address these critical deficiencies.