# FDA 483 - AutoMedx, LLC - January 18, 2024

Source: https://www.globalkeysolutions.net/records/483/automedx-llc/f23daca2-2004-4dac-a5bc-858871a45bc2

> FDA 483 for AutoMedx, LLC on January 18, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AutoMedx, LLC
- Inspection Date: 2024-01-18
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: AutoMedx, LLC, a specification developer in Addison, TX, was cited for significant deficiencies in its quality system during an FDA inspection from January 9-18, 2024. The inspection revealed failures in complaint handling, supplier controls, internal quality audits, and management review procedures, with several issues being repeat observations. These findings indicate a systemic lack of adherence to established quality system requirements.

## Related Documents

- [483 - 2020-01-24](https://www.globalkeysolutions.net/records/483/automedx-llc/48dfacfd-2514-42f5-937a-dea294d2476b)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/olalere-d-fasipe/0dd0f0ae-07d9-40ab-b602-97521150d23d)

Company: https://www.globalkeysolutions.net/companies/automedx-llc/37535d09-8597-4625-a2e6-8588c0beb25e

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab