HG Medical USA, LLCOctober 28, 2021

FDA 483 - HG Medical USA, LLC - October 28, 2021

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Record Details

HG Medical USA, LLC in Huntington, WV, was inspected from October 25-28, 2021. The inspection revealed one significant observation concerning the firm's failure to adequately establish records for acceptable suppliers and contractors. Specifically, the firm did not properly approve or audit several critical suppliers of components and services, including those for endotoxin testing, manufacturing components, water treatment, and passivation equipment.

Company: HG Medical USA, LLC
Inspection Date: October 28, 2021
Product Type: Device
Office: Office of Regulatory Affairs
Person: Tiki Dixon

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ID · 77c361a3-99d9-485d-91a5-36eaa0ec6ebd