FDA EIR - Ethicon Endo-Surgery Inc - June 11, 2014

An FDA inspection of Ethicon Endo-Surgery Inc. at its Cincinnati, Ohio facility was conducted from June 2 to June 11, 2014. The inspection focused on the company's manufacturing of Class I and Class II medical devices, specifically computer-assisted personalized sedation systems and surgical staplers. This visit was prompted by a post-market review for the Sedasys Computer-Assisted Personalized Sedation System and an inquiry into a high volume of Medical Device Reports related to surgical staplers. A comprehensive Quality System Inspection Technique (QSIT) Level 2 assessment also evaluated management controls, design controls, corrective and preventive actions (CAPA), and purchasing controls. The regulatory oversight adhered to established guidelines for medical device manufacturers and premarket approval/postmarket inspections. Significantly, the inspection concluded with "No Action Indicated," meaning no objectionable conditions or regulatory violations were identified. As a result, no FDA Form 483 was issued, and no immediate corrective actions were required from the company.