FDA EIR - Convatec, A Bristol-Myers Squibb Co. - September 11, 2013

A U.S. Food and Drug Administration (FDA) inspection was conducted at Convatec, A Bristol-Myers Squibb Co., located in Greensboro, NC, from September 9 to September 11, 2013. This routine inspection was carried out under Compliance Program 7382.845 for Medical Device Manufacturers, focusing on medical device regulations. The inspection utilized a Level 1 Quality System Inspection Technique (QSIT) approach, covering critical subsystems such as Corrective and Preventive Action (CAPA), Management Control, and Production and Process controls. Additionally, the firm's Medical Device Reporting system was reviewed. The scope included an examination of various operational and quality system records, including standard operating procedures, complaint handling, non-conforming products, and employee training, as well as manufacturing and sterilization processes for their Gentle Touch family of products. A significant finding of this inspection was that no significant objectionable conditions or violations were observed. All reviewed procedures for CAPA, Medical Device Reporting, quality management, internal audits, and equipment maintenance appeared to be adequately established and implemented. Consequently, no specific regulatory actions or corrective measures were required from Convatec as a direct result of this inspection. The firm was reminded of its ongoing responsibility to maintain operations in compliance with the Federal Food, Drug, and Cosmetic Act.