# FDA 483 - AxioMed, LLC. - January 13, 2023

Source: https://www.globalkeysolutions.net/records/483/axiomed-llc/bc442d76-2014-415d-b498-c6226ab508ff

> FDA 483 for AxioMed, LLC. on January 13, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AxioMed, LLC.
- Inspection Date: 2023-01-13
- Product Type: device
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: AxioMed, LLC. in Malden, MA, was inspected by the FDA from December 15, 2022, to January 13, 2023. The inspection revealed that the firm failed to submit annual progress reports for a significant risk device study to the FDA. Specifically, reports due in 2015, 2017, and 2019 were not submitted as required.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/jose-a-torres/0c491014-1dd0-4024-99b2-203b830b9c2b)

Company: https://www.globalkeysolutions.net/companies/axiomed-llc/1a1b4e57-8e84-40c7-835a-8bb14478182b

Office: https://www.globalkeysolutions.net/offices/fda-district-office-stoneham-massachusetts/1daceb4f-4057-46cf-af02-d4ccde44dcc7