OSRX Inc.
Form 483 issued November 14, 2025 · Missoula, Montana
- Inspection
- Nov 3 – Nov 14, 2025
- Investigators
- Rowena S. Nguyen· Thuy T. Nguyen
- Observations
- 4
- Pages
- 7
- FEI number
- 3014549846
In short: On November 14, 2025, FDA issued a Form 483 with 4 observations to OSRX Inc. in Missoula, Montana (FEI 3014549846) after an inspection that ran Nov 3 – Nov 14, 2025. The investigators were Rowena S. Nguyen and Thuy T. Nguyen. Most observations concern production and quality system.
At a glance
Observations span 4 systems, led by production.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 02
Written records of investigations into unexplained discrepancies do not always include…
- 03
The reproducibility of test methods…
- 04
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
This inspection in context
Rowena S. Nguyen
12 documents · 2022–2026
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in California.
The firmOSRX Inc. history
All 6 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at OSRX Inc.?
FDA listed 4 observations on this Form 483, mostly about production, quality system and laboratory controls. The opening words of each observation are shown on this page.
Who inspected OSRX Inc.?
Rowena S. Nguyen and Thuy T. Nguyen are named on this Form 483, for the inspection of Nov 3 – Nov 14, 2025. Each investigator has a profile showing what they cite most.
When was OSRX Inc. inspected by FDA?
The inspection ran Nov 3 – Nov 14, 2025, and the Form 483 is dated November 14, 2025.
How do I get the full Form 483 for OSRX Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.