Gyrus ACMI, Inc. – FDA EIR, Jan 14, 2020

The FDA conducted an inspection of Gyrus ACMI, Inc. in Brooklyn Park, MN, on January 14, 2020. This inspection was assigned under two FY2020 CDRH risk-based work plan assignments, focusing on laparoscopic insufflators and accessories, and bronchoscopes/nasopharyngoscopes. The regulatory framework guiding the inspection included Compliance Program 7382.845, "Inspection of Medical Device Manufacturers." It was determined that Gyrus ACMI no longer manufactured the specific laparoscopic insufflators (UHI-3) relevant to one assignment, having discontinued them in 2013. For the second assignment, the firm's bronchoscope accessories (Peri View Flex Single Use Aspiration Needle) were single-use and classified under a different product code (KTI) than the one targeted (EOQ), thus falling outside the scope of reprocessing concerns. Consequently, no significant violations were identified, and no FDA-483, Inspectional Observations, was issued. The main required actions for Gyrus ACMI involved updating their FDA registration to accurately reflect current manufacturing activities by removing the discontinued UHI-3 insufflator and correcting the product code for the Peri View Flex Single Use Aspiration Needle from EOQ to KTI.