Cohance Lifesciences announced that the United States Food and Drug Administration (USFDA) conducted an inspection of its Pashamylaram, Hyderabad manufacturing facility from July 27 to August 5, 2026. The inspection resulted in five observations noted on a Form FDA 483. Importantly, none of these observations relate to data integrity issues. The company is committed to addressing these points and is preparing a comprehensive response with corrective and preventive actions (CAPAs).
USFDA Inspection Conducted at Hyderabad Facility
Cohance Lifesciences has disclosed that the United States Food and Drug Administration (USFDA) recently inspected its manufacturing facility located in Pashamylaram, Hyderabad. The inspection took place from July 27, 2026, through August 5, 2026. The facility’s FEI number is 1000623515.
Observations and Next Steps
At the conclusion of the inspection process, the company received a Form FDA 483, which contained a total of five observations. Cohance Lifesciences has emphasized that none of these observations pertain to data integrity issues. The company is currently undertaking a detailed assessment of the identified observations and is in the process of formulating a comprehensive response. This response will include the implementation of appropriate corrective and preventive actions (CAPAs), which will be submitted to the USFDA within the stipulated timeframe.
Commitment to Quality and Compliance
Cohance Lifesciences reiterated its dedication to maintaining the highest standards of quality and regulatory compliance across its operations. The company believes that the observations are addressable and intends to work closely and constructively with the USFDA to ensure their timely and effective resolution. The company remains committed to continuous improvement in its operations and to upholding robust quality systems that prioritize patient safety and regulatory adherence.
Source: BSE
