# FDA EIR - Gyrus ACMI, Inc. - January 14, 2020

Source: https://www.keypedia.com/records/eir/gyrus-acmi-inc/3092009f-92b1-4762-b827-8b377290cfb4

> FDA EIR for Gyrus ACMI, Inc. on January 14, 2020. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: EIR
- Company Name: Gyrus ACMI, Inc.
- Inspection Date: 2020-01-14
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: 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.

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Company: https://www.keypedia.com/companies/gyrus-acmi-inc/cc021f12-0ca9-4ff6-b22a-d5cdd858904d

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7