FDA EIR - Gyrus ACMI, Inc. - January 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.