OSRX Inc.
FDA inspection history across 2 sites, 2019 to 2025
- 4
- Form 483s
- 2
- Warning letters
Every document, by year
- Form 483
- Warning letter
2019: one Form 483; 2020: one warning letter; 2021: one Form 483; 2024: one Form 483; 2025: one Form 483 and one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2019–21Two Form 483s and one warning letter, at Missoula, Montana and Montana.
- 2024–25Two Form 483s and one warning letter, at Missoula, Montana.
- 2024The longest 483 on file: 6 observations over 8 pages at Missoula, Montana.
Cited most
Across all OSRX observations on file
- 21 CFR 211.113Control of microbiological contamination3
- 21 CFR 211.192Production record review2
- 21 CFR 211.165Testing and release for distribution1
- 21 CFR 211.167(a)Special testing requirements1
- 21 CFR 211.198Complaint files1
The complete OSRX file.
All 6 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Missoula, Montana
Four Form 483s and one warning letter · 2019 to 2025 · 12 observations
Latest: Form 483, Nov 14, 2025 →Montana
One warning letter · 2020
Latest: Warning letter, Oct 5, 2020 →
Documents
6 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-11-14 | 483 Form 483 | Missoula, Montana | 4 | $99 |
| 2025-04-23 | Warning letter Warning letter | Missoula, Montana | — | $99 |
| 2024-10-25 | 483 Form 483 | Missoula, Montana | 6 | $99 |
| 2021-09-23 | 483 Form 483 | Missoula, Montana | 1 | $99 |
| 2020-10-05 | Warning letter Warning letter | Montana | — | $99 |
| 2019-04-25 | 483 Form 483 | Missoula, Montana | 1 | $99 |
Investigators on these documents
Andrew K. Haack (1)Christopher R. Czajka (1)Jazmine N. Brown (1)Kenneth O. Gee (1)Rowena S. Nguyen (1)Sangeeta M. Khurana (1)Thuy T. Nguyen (1)
FEI number 3014549846 · most recent document Nov 14, 2025
About OSRX Inc.
How many FDA Form 483s has OSRX Inc. received?
FDA Intel has 4 Form 483s on file for OSRX Inc.; the most recent is dated Nov 14, 2025.
When was OSRX Inc. last inspected by FDA?
The most recent FDA inspection document on file for OSRX Inc. is a Form 483 dated Nov 14, 2025, for the site in Missoula, Montana.
What did FDA cite at OSRX Inc.?
The regulations cited most in the observations on file for OSRX Inc. are 21 CFR 211.113 (Control of microbiological contamination), 3 times; 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.165 (Testing and release for distribution), 1 time.
Has OSRX Inc. received an FDA warning letter?
Yes. FDA Intel has 2 FDA warning letters on file for OSRX Inc.; the most recent is dated Apr 23, 2025.