FDA EIR - Degania Medical Devices Pvt. Ltd. - November 07, 2019

The FDA conducted a routine inspection of Degania Medical Devices Pvt. Ltd. in Gurgaon, Haryana, India, from November 4-7, 2019. The inspection assessed the firm's adherence to the Quality System Regulation for medical device manufacturers. Investigators identified significant compliance deficiencies, documented on an FDA Form 483.

Key violations included inadequate procedures for controlling non-conforming products, characterized by delayed non-conformance reports and a lack of root cause investigations for rejected batches. Furthermore, the company's acceptance activities procedures were not adequately established, allowing for repeated retesting of out-of-tolerance products until they met specifications. Critical issues were also found in complaint handling, where procedures lacked provisions for uniform and timely processing, proper documentation upon receipt, and essential Medical Device Report (MDR) evaluations. Lastly, the firm had not developed written MDR procedures as required.

Degania Medical Devices' management, led by Director of Operations Vikas Jund, acknowledged the observations and committed to corrective actions. The company is required to promptly establish comprehensive procedures addressing non-conforming product control, refine acceptance testing protocols, and implement robust complaint and MDR handling systems. A written response detailing these corrections was promised within fifteen working days.