FDA WARNING_LETTER - Cohance Lifesciences Limited - August 12, 2025

The FDA issued a Warning Letter to Cohance Lifesciences Limited following an inspection of its drug manufacturing facility from August 4 to August 12, 2025. The letter highlights significant violations of Current Good Manufacturing Practice (CGMP) regulations, deeming the company"s drug products adulterated.Key issues identified include the firm"s failure to thoroughly investigate unexplained discrepancies and product failures. For instance, customer complaints of crumbling tablets lacked adequate root-cause determination and effective corrective actions. The FDA found the company"s response insufficient, requiring further testing of affected samples and a comprehensive assessment of the investigation system.Additionally, the company failed to properly clean and maintain manufacturing equipment. Investigators observed visible stains and residues on "clean" equipment, which analytical testing confirmed contained multiple active pharmaceutical ingredients, indicating potential cross-contamination. The FDA requires a comprehensive, independent retrospective assessment of cleaning effectiveness, a robust corrective and preventive action (CAPA) plan, and improvements to cleaning procedures.Finally, Cohance Lifesciences Limited did not establish and follow adequate written procedures for equipment cleaning. The existing cleaning validation study was insufficient, and new drug products introduced on shared equipment were not properly re-evaluated, potentially leading to contamination. The FDA mandates significant improvements to the cleaning validation program, emphasizing worst-case scenarios and updated standard operating procedures.The company has temporarily suspended manufacturing for the U.S. market and must clarify its intent to resume operations. To achieve compliance, Cohance Lifesciences must resolve all identified deficiencies and systemic flaws, as failure to do so could result in withheld drug approvals or refusal of product admission into the United States.