Cohance Lifesciences Receives 5 Observations from USFDA Inspection

Cohance Lifesciences Ltd announced the completion of a USFDA inspection at its Pashamylaram, Hyderabad manufacturing facility. The inspection, conducted from July 27 to August 5, 2026, resulted in a Form FDA 483 with five observations. Importantly, none of these observations pertain to data integrity issues. The company is currently assessing the observations and preparing a comprehensive response with corrective and preventive actions (CAPAs) for submission within the stipulated timeline. Cohance Lifesciences expressed confidence in the addressability of the observations and its commitment to working constructively with the USFDA for timely resolution, emphasizing its dedication to quality, regulatory compliance, and patient safety.