FDA EIR - Degania Medical Devices Pvt. Ltd. - January 21, 2016

An FDA inspection of Degania Medical Devices Pvt. Ltd. in Gurgaon, India, conducted from January 18-21, 2016, identified a critical issue regarding process validation documentation. The company, a manufacturer of Class II medical devices, received a Form FDA 483 for failing to adequately document sterilization requalification activities. Specifically, the report for Sterilizer #1 did not detail the precise placement of biological indicators within Foley catheters, which contravenes established protocols and regulatory requirements outlined in 21 CFR 820.75(a) of the Quality System Regulation. This inspection was a follow-up to an August 2014 visit that led to a Warning Letter citing multiple deficiencies, including inadequate control of documents, quality system records, device history records, process validation, non-conforming product control, and corrective and preventive actions. While Degania Medical Devices had initiated various corrective measures for these previous findings, the current inspection highlighted persistent gaps in comprehensive validation documentation. As required actions, the company made immediate on-the-spot corrections by updating relevant Standard Operating Procedures (SOPs) to ensure future validation reports fully reflect protocol information. Management committed to submitting a formal written response to the FDA 483 within 15 business days, detailing further corrective and preventive actions and affirming their dedication to continuous quality improvement.