# FDA 483 - Spirus Medical, LLC - November 18, 2022

Source: https://www.keypedia.com/records/483/spirus-medical-llc/4829deaa-8bb0-40ce-a9e2-40aed35ca219

> FDA 483 for Spirus Medical, LLC on November 18, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Spirus Medical, LLC
- Inspection Date: 2022-11-18
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: Spirus Medical, LLC in West Bridgewater, MA was inspected by the FDA from November 15-18, 2022. The inspection revealed a significant issue with the firm's complaint handling procedures. Specifically, the firm's procedures were not adequately established, with deficiencies noted in documentation, record usage, required signatures, and the recording of unique device identifiers for products.

## Related Officers

- [investigator](https://www.keypedia.com/people/james-p-finn/70e5c36c-2711-449b-bf73-e08b4dd58449)

Company: https://www.keypedia.com/companies/spirus-medical-llc/e066bbff-5c45-424c-a35a-2f2c1c54e483

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