FDA 483 - Oxarc Inc - August 23, 2019

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.