OSRX Inc.
Form 483 issued September 23, 2021 · Missoula, Montana
- Inspection
- Sep 15 – Sep 23, 2021
- Investigators
- Kenneth O. Gee· Sangeeta M. Khurana
- Observations
- 1
- Pages
- 2
- FEI number
- 3014549846
In short: On September 23, 2021, FDA issued a Form 483 with 1 observation to OSRX Inc. in Missoula, Montana (FEI 3014549846) after an inspection that ran Sep 15 – Sep 23, 2021. The investigators were Kenneth O. Gee and Sangeeta M. Khurana. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm's current laminar air flow studies (smoke studies) of the ISO 5 (b)(4) Laminar Airflow…
This inspection in context
Kenneth O. Gee
9 documents · 2017–2022
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Washington.
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 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected OSRX Inc.?
Kenneth O. Gee and Sangeeta M. Khurana are named on this Form 483, for the inspection of Sep 15 – Sep 23, 2021. Each investigator has a profile showing what they cite most.
When was OSRX Inc. inspected by FDA?
The inspection ran Sep 15 – Sep 23, 2021, and the Form 483 is dated September 23, 2021.
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.