# FDA 483 - Gyrus ACMI, Inc. - November 02, 2023

Source: https://www.keypedia.com/records/483/gyrus-acmi-inc/592a45df-2870-43e8-8ebd-75461696e985

> FDA 483 for Gyrus ACMI, Inc. on November 02, 2023. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Gyrus ACMI, Inc.
- Inspection Date: 2023-11-02
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: An FDA inspection of Gyrus ACMI, Inc. in Littleton, MA, revealed significant deficiencies in their quality system for medical device manufacturing. The firm failed to adequately maintain device history records, establish proper complaint handling procedures, and effectively implement corrective and preventive actions. These issues indicate a systemic breakdown in ensuring device quality and regulatory compliance.

## Related Documents

- [WARNING_LETTER - 2012-08-02](https://www.keypedia.com/records/warning_letter/gyrus-acmi-inc/94dac061-4594-413d-a0de-c4a6310e40bc)

## Related Officers

- [Sunita Pandey](https://www.keypedia.com/people/sunita-pandey/008e5bb8-0eb3-45d8-8524-734ac0454250)

Company: https://www.keypedia.com/companies/gyrus-acmi-inc/83de7ea8-de1b-4b07-805a-975da3d94ea6

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94