FDA EIR - Ethicon Endo-Surgery Inc - August 04, 2023

An unannounced, directed inspection of Ethicon Endo-Surgery Inc. in Blue Ash, OH, was conducted by the FDA from August 1 to August 4, 2023. The inspection focused on the company's manufacturing of Class 2 sterile endoscopic devices and accessories, specifically evaluating its Corrective and Preventive Action (CAPA) and Purchasing Controls systems. The regulatory framework for this inspection included C/P 7382.845, "Inspection of Medical Device Manufacturers." Investigators also reviewed various existing Class 1 and Class 2 recalls, such as RES83897, RES84280, RES88349, RES88434, and several customer complaints related to Class II devices. This included examining the firm's procedures for CAPA, complaint handling, and field actions. During the course of this inspection, no observations were noted. This indicates that the company's reviewed systems and processes were found to be in compliance with regulatory requirements at the time of the inspection, and therefore, no new regulatory actions were required as a direct result of this specific assessment. The firm also participates in the Medical Device Single Audit Program (MDSAP).