The United States Food and Drug Administration (US FDA) has concluded a comprehensive regulatory inspection at CohanceLifesciences’ Finished Dosage Formulation (FDF) manufacturing facility located in Shamshabad, Hyderabad.
The on-site audit spanned nine consecutive days, reflecting a thorough evaluation of current Good Manufacturing Practices (cGMP), process controls, and quality management systems across the facility. At the conclusion of the inspection, the U.S. regulatory agency issued a Form 483 citing four procedural and compliance observations.
A Form 483 communicates areas where conditions or practices may deviate from U.S. statutory standards and does not represent an enforcement ban, a warning letter, or an order to stop commercial manufacturing operations. In response to the findings, Cohance Lifesciences is formulating a comprehensive Corrective and Preventive Action (CAPA) plan. The company will address each specific observation with targeted remediation steps and definitive implementation timelines, which will be formally submitted to the agency within the mandated response window.
Cohance Lifesciences reiterated its focus on cGMP compliance, patient safety, and high-quality production standards, confirming it will collaborate closely with the U.S. FDA to ensure swift, effective resolution of the noted items.
Written by: Pragna Biswas
Graphics by: Pramit Hazra
