Oxarc IncAugust 23, 2019

FDA 483 - Oxarc Inc - August 23, 2019

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Record Details

Oxarc Inc, a medical gas manufacturer in Coeur d Alene, ID, was cited for two observations during an FDA inspection. The firm failed to properly qualify and maintain a new gas analyzer used for medical oxygen, and did not initiate required change control. Additionally, the inspection found a lack of documented cGMP and procedural training for employees involved in filling medical oxygen gas.

Company: Oxarc Inc
Inspection Date: August 23, 2019
Product Type: Drugs
Office: Division of Human and Animal Food Operations - West VI
Person: Anita Narula (Compliance Officer - CDER/OC/OMQ)

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ID · f8e9547f-83eb-4949-bd58-a4d2065fc4bd