FDA EIR - Ethicon Endo-Surgery Inc - June 05, 2015

An FDA inspection of Ethicon Endo-Surgery Inc. (EES), a medical device manufacturer located in Blue Ash, OH, was conducted from June 1-5, 2015. This was a for-cause inspection focusing on Corrective and Preventive Actions (CAPA) and Design Controls, prompted by consumer complaints regarding foreign material found within sterile-packaged medical devices. The primary concern involved 'flash,' or small particulates, generated during the manufacturing process of devices like the Echelon Endocutter product line. Despite the focus on these complaints and related processes, the inspection concluded without the issuance of an FDA-483, Inspectional Observations, indicating no formal violations were identified at that time. However, two significant discussion items were raised with company management. Firstly, the FDA investigator noted that EES had classified two product issues as Class III recalls (one for Sedasys software anomalies and another for Echelon Endopath devices due to physician cartridge selection) but did not formally submit them to the FDA for review. This practice was highlighted for potential further review by the FDA's recall coordinator. Secondly, management was reminded of the importance of thoroughly documenting all complaint and CAPA investigations, including comprehensive reviews of all relevant risks. While initial documentation raised questions, the firm ultimately provided sufficient evidence to address these concerns before the inspection concluded.