FDA EIR - Amcor Flexibles Inc - September 09, 2016

An FDA Level II inspection of Amcor Flexibles Inc, located in Mundelein, IL, was conducted from September 7-9, 2016. The company serves as a contract manufacturer of Class II medical devices, specifically tyvek pouches and rolls featuring sterilization indicators, used for sterilizing surgical instruments in healthcare facilities. The inspection was carried out under Compliance Program 7382.845, focusing on Medical Device Manufacturers. Key areas reviewed included Management Controls, Corrective and Preventive Actions (CAPA) systems, and Production and Process Controls. The review encompassed internal audits, complaint records, CAPAs, statistical analyses, and Device History Records from the preceding two years. Importantly, this inspection revealed no deficiencies, and consequently, no Form FDA 483, Inspectional Observations, was issued to Amcor Flexibles Inc. This indicates that the facility was found to be operating in compliance with applicable medical device regulations during the inspection period, requiring no further immediate regulatory actions.