# FDA 483 - OSRX Inc. - September 23, 2021

Source: https://www.globalkeysolutions.net/records/483/osrx-inc/8b8c2491-c4fa-4446-842d-b3703af5f421

> FDA 483 for OSRX Inc. on September 23, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: OSRX Inc.
- Inspection Date: 2021-09-23
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: OSRX, Inc. dba Pinnacle Compounding in Missoula, MT, a producer of sterile drug products, was inspected by the FDA. The inspection revealed a significant concern regarding the firm's laminar airflow studies (smoke studies). These studies were found not to be representative of current aseptic compounding practices, failing to simulate critical operations and interventions used during sterile drug production.

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## Related Officers

- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/kenneth-o-gee/d61312c0-1422-4487-a5d6-ec6e76d242ee)
- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/sangeeta-m-khurana/bed4533f-a9aa-47c5-9e0b-f20ad36461aa)

Company: https://www.globalkeysolutions.net/companies/osrx-inc/aead9fd9-6208-40fd-bc2a-d477072c53ae

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