Airgas USA LLC
Form 483 issued October 25, 2019 · Salt Lake City, Utah
- Inspection
- Oct 24 – Oct 25, 2019
- Investigator
- Nayan J. Patel
- Observations
- 1
- Pages
- 2
- FEI number
- 1717226
In short: On October 25, 2019, FDA issued a Form 483 with 1 observation to Airgas USA LLC in Salt Lake City, Utah (FEI 1717226) after an inspection that ran Oct 24 – Oct 25, 2019. The investigator was Nayan J. Patel. Most observations concern production; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.100(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
There are no written procedures for production and process controls designed to assure that the drug…
This inspection in context
Nayan J. Patel
11 documents · 2017–2023
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Utah.
The firmAirgas USA LLC history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Airgas USA LLC?
FDA listed 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Airgas USA LLC?
Nayan J. Patel is named on this Form 483, for the inspection of Oct 24 – Oct 25, 2019. Each investigator has a profile showing what they cite most.
When was Airgas USA LLC inspected by FDA?
The inspection ran Oct 24 – Oct 25, 2019, and the Form 483 is dated October 25, 2019.
How do I get the full Form 483 for Airgas USA LLC?
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.