AutoMedx, LLCJanuary 18, 2024

FDA 483 - AutoMedx, LLC - January 18, 2024

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Record Details

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.

Company: AutoMedx, LLC
Inspection Date: January 18, 2024
Product Type: Device
Office: Division of Human and Animal Food Operations - West III
Person: Olalere D. Fasipe (investigator)

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ID · f23daca2-2004-4dac-a5bc-858871a45bc2