# FDA 483 - OSRX Inc. - November 14, 2025

Source: https://www.keypedia.com/records/483/osrx-inc/49b3bcff-f634-4b2c-82d6-24709feeea2f

> FDA 483 for OSRX Inc. on November 14, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: OSRX Inc.
- Inspection Date: 2025-11-14
- Product Type: drugs
- Office Name: Seattle District Office
- Summary: OSRX Inc., an outsourcing facility in Missoula, MT, was inspected and cited for significant deficiencies in its manufacturing and quality control systems. The inspection revealed failures in preventing microbiological contamination during sterile drug production, including inadequate aseptic process simulations and smoke studies, some of which were repeat observations. Additionally, the firm's complaint handling and out-of-specification investigations were found to be insufficient, and critical laboratory test methods lacked established reproducibility and proper computer system controls.

## Related Documents

- [483 - 2019-04-25](https://www.keypedia.com/records/483/osrx-inc/23b35fd9-37bc-4337-a5ff-a8a3bc4ab546)
- [UNTITLED_LETTER - 2020-10-05](https://www.keypedia.com/records/untitled_letter/osrx-inc/55208b4e-a92a-46aa-9ac1-dc41a33636ff)
- [483 - 2021-09-23](https://www.keypedia.com/records/483/osrx-inc/8b8c2491-c4fa-4446-842d-b3703af5f421)
- [483 - 2021-09-23](https://www.keypedia.com/records/483/osrx-inc/6ea8732b-3598-4fdd-a4e4-2408b73eac91)
- [483 - 2024-10-25](https://www.keypedia.com/records/483/osrx-inc/9e1d6adc-0959-4fe9-a0fd-acc5b7399fb2)

## Related Officers

- [Rowena S. Nguyen](https://www.keypedia.com/people/rowena-s-nguyen/ae39318e-1653-467c-94cc-26f8929441ac)
- [Thuy Tram L. Nguyen](https://www.keypedia.com/people/thuy-tram-l-nguyen/b58f2445-728e-4f79-b7eb-4dfb7e982e25)

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

Office: https://www.keypedia.com/offices/seattle-district-office/9305837f-0738-4075-b444-a55e7a2b8913