# FDA 483 - Signifier Medical Technologies, Llc - July 15, 2022

Source: https://www.keypedia.com/records/483/signifier-medical-technologies-llc/cee0dd2f-b83d-4d97-a9b6-f442bde59e95

> FDA 483 for Signifier Medical Technologies, Llc on July 15, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Signifier Medical Technologies, Llc
- Inspection Date: 2022-07-15
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: Signifier Medical Technologies, Llc, a medical device manufacturer, was cited for significant deficiencies in its corrective and preventive action (CAPA) procedures. The inspection revealed incomplete corrective action reports, missed due dates, and a failure to adequately address U.S. regulatory requirements under 21 CFR 820.100. These issues indicate a lack of robust quality system controls.

## Related Officers

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

Company: https://www.keypedia.com/companies/signifier-medical-technologies-llc/b72d68bf-04f4-4cb7-9c21-84cff5cee916

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