# FDA 483 - Oxarc Inc - August 23, 2019

Source: https://www.keypedia.com/records/483/oxarc-inc/f8e9547f-83eb-4949-bd58-a4d2065fc4bd

> FDA 483 for Oxarc Inc on August 23, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Oxarc Inc
- Inspection Date: 2019-08-23
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: 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.

## Related Officers

- [Compliance Officer - CDER/OC/OMQ](https://www.keypedia.com/people/anita-narula/fbebf5a2-e25c-4e98-9c22-433d9102380c)

Company: https://www.keypedia.com/companies/oxarc-inc/04ae382c-1e3b-4b6e-b578-e4d1597c85b3

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-vi/6e5a2a08-f464-4979-a759-7b0383370822