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

Source: https://www.keypedia.com/records/483/automedx-llc/954069e3-b9d1-487a-b2bf-03c63cc2ee1b

> FDA 483 for AutoMedx, LLC on January 18, 2024. Product: devices. 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: devices
- Office Name: Dallas District Office
- Summary: An FDA inspection of AutoMedx, LLC, an Addison, TX-based specification developer, was conducted from January 9-18, 2024. The inspection resulted in a Form FDA 483 listing four observations related to deficiencies in the company's quality system. Key issues included inadequate procedures for receiving, reviewing, and evaluating customer complaints, with specific failures to document complaints properly and timely assess them for potential Medical Device Reporting (MDR) events, as required by regulatory standards. The firm also lacked adequate procedures for ensuring purchased products and services conformed to specified requirements, notably failing to document evaluations of critical suppliers since 2020. This was a repeat observation from a previous inspection. Additionally, AutoMedx, LLC did not establish procedures for internal quality audits, with no documentation of audits conducted for 2021 and 2023, which was also a repeat finding. Finally, the company exhibited inadequate procedures for management review, with no documented management review meetings for 2021, 2022, and 2023. AutoMedx has committed to correcting all identified deficiencies to ensure compliance with FDA quality system requirements.

## Related Documents

- [483 - 2020-01-24](https://www.keypedia.com/records/483/automedx-llc/48dfacfd-2514-42f5-937a-dea294d2476b)
- [483 - 2024-01-18](https://www.keypedia.com/records/483/automedx-llc/f23daca2-2004-4dac-a5bc-858871a45bc2)

## Related Officers

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

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

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9