# FDA 483 - Gyrus ACMI, Inc. - November 12, 2025

Source: https://www.keypedia.com/records/483/gyrus-acmi-inc/99396a22-e9a3-47de-bfc3-abcdb9c9856d

> FDA 483 for Gyrus ACMI, Inc. on November 12, 2025. Product: devices. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Gyrus ACMI, Inc.
- Inspection Date: 2025-11-12
- Product Type: devices
- Office Name: Minneapolis District Office
- Summary: From October 6 to November 12, 2025, the FDA inspected the Gyrus ACMI, Inc. manufacturing facility in Brooklyn Park, Minnesota. The inspection identified several significant violations of quality system requirements under the Federal Food, Drug, and Cosmetic Act. Key issues included the failure to adequately validate sterile barrier sealing processes, where equipment was used without proving it could consistently meet safety standards. The firm also demonstrated insufficient supplier oversight, notably continuing to use components with known welding defects and failing to justify why certain supplier data was accepted after initial testing failed. Additionally, the inspection highlighted major deficiencies in the Corrective and Preventive Action (CAPA) program. The company frequently closed safety investigations without taking corrective steps and failed to update risk assessments even after product recalls occurred. Other noted violations involved inadequate monitoring of production parameters, inconsistent testing of incoming parts, and incomplete records for device history and complaint investigations. In response to these findings, Gyrus ACMI, Inc. has pledged to correct the identified problems. The firm is expected to implement comprehensive corrective actions and provide the FDA with documented evidence that these improvements have been effectively integrated into their quality management systems to ensure product safety and regulatory compliance.

## Related Documents

- [EIR - 2020-01-14](https://www.keypedia.com/records/eir/gyrus-acmi-inc/3092009f-92b1-4762-b827-8b377290cfb4)

## Related Officers

- [Investigator ](https://www.keypedia.com/people/christina-l-bigham/f3da8e26-4a8c-43a8-8070-349fe4500289)

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

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d