Airgas USA LLC
Form 483 issued December 16, 2024 · Salt Lake City, Utah
- Inspection
- Dec 12 – Dec 16, 2024
- Investigator
- Nicholas L. Hunt
- Observations
- 2
- Pages
- 3
- FEI number
- 1717226
In short: On December 16, 2024, FDA issued a Form 483 with 2 observations to Airgas USA LLC in Salt Lake City, Utah (FEI 1717226) after an inspection that ran Dec 12 – Dec 16, 2024. The investigator was Nicholas L. Hunt. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Facilities & equipment and laboratory controls account for 2 of 2 observations.
Most cited: 21 CFR 211.68(a) (1×) · 211.160(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Routine calibration of equipment is not performed according to a written program designed…
- 02
The establishment of sampling plans including any changes thereto, are not drafted by the appropriate organizational…
This inspection in context
Nicholas L. Hunt
38 documents · 2017–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Arizona.
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 211.68(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Airgas USA LLC?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Airgas USA LLC?
Nicholas L. Hunt is named on this Form 483, for the inspection of Dec 12 – Dec 16, 2024. Each investigator has a profile showing what they cite most.
When was Airgas USA LLC inspected by FDA?
The inspection ran Dec 12 – Dec 16, 2024, and the Form 483 is dated December 16, 2024.
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.