OSRX Inc.
Form 483 issued October 25, 2024 · Missoula, Montana
- Inspection
- Oct 16 – Oct 25, 2024
- Investigator
- Jazmine N. Brown
- Observations
- 6
- Pages
- 8
- FEI number
- 3014549846
In short: On October 25, 2024, FDA issued a Form 483 with 6 observations to OSRX Inc. in Missoula, Montana (FEI 3014549846) after an inspection that ran Oct 16 – Oct 25, 2024. The investigator was Jazmine N. Brown. Most observations concern quality system and production.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
Each batch of drug product purporting to be sterile and pyrogen-free is not laboratory tested to…
This inspection in context
Jazmine N. Brown
14 documents · 2022–2025
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Pennsylvania.
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(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at OSRX Inc.?
FDA listed 6 observations on this Form 483, mostly about quality system, production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected OSRX Inc.?
Jazmine N. Brown is named on this Form 483, for the inspection of Oct 16 – Oct 25, 2024. Each investigator has a profile showing what they cite most.
When was OSRX Inc. inspected by FDA?
The inspection ran Oct 16 – Oct 25, 2024, and the Form 483 is dated October 25, 2024.
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.