FDA EIR - ConvaTec, Inc - September 08, 2015

A follow-up medical device establishment inspection of ConvaTec in Greensboro, NC, was conducted by the FDA from August 31 to September 8, 2015. This inspection, assigned as an Official Action Indicated (OAI) Compliance Follow-up, focused on Medical Device Reporting (MDR) Regulations and Medical Device Level III compliance, adhering to Compliance Program 73825.845 for medical device manufacturers. The scope included the firm's Corrective Action and Preventive Action (CAPA), complaint, MDR handling, and Design Control procedures.

While the current inspection did not result in a formal FDA-483 listing significant deficiencies, four observations were discussed with ConvaTec's management. These included inadequate documentation of device history record reviews during complaint investigations, a lack of documented evidence for requests to return non-conforming devices, and investigation procedures that did not specify timely completion for both customer complaints and CAPAs. Specifically, the firm's 90-day initial investigation timeframe was deemed too long. Additionally, complaint investigation records often lacked sufficient detail regarding when and how nonconforming devices were identified. ConvaTec's management acknowledged these observations and committed to implementing necessary Quality System improvements to address them. The firm has made progress in addressing previous design control observations.