# FDA 483 - KX Medical Inc - January 21, 2025

Source: https://www.keypedia.com/records/483/kx-medical-inc/cda64966-848a-437b-99dd-92b13e45bf9f

> FDA 483 for KX Medical Inc on January 21, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: KX Medical Inc
- Inspection Date: 2025-01-21
- Product Type: device
- Office Name: New Orleans District Office
- Summary: An FDA inspection of KX Medical Inc in Gallatin, TN, from January 15-21, 2025, identified one observation. The firm's procedures for acceptance activities were found to be inadequate. Specifically, the procedures failed to designate an individual for final product release and did not mandate the signature of an authorized individual.

## Related Officers

- [investigator](https://www.keypedia.com/people/nikki-s-bryant/fe859d4f-23a6-4bc9-94c6-5b3c3fe8d99a)

Company: https://www.keypedia.com/companies/kx-medical-inc/b2b9b370-31ee-4cb5-b9ba-84e2d18fc62e

Office: https://www.keypedia.com/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea