Airgas USA, LLC
Form 483 issued October 29, 2021 · Colorado Springs, Colorado
- Inspection
- Oct 27 – Oct 29, 2021
- Investigators
- Dogbeda F. Mackenzie· Matthew R. Clabeaux
- Observations
- 2
- Pages
- 4
- FEI number
- 1718463
In short: On October 29, 2021, FDA issued a Form 483 with 2 observations to Airgas USA, LLC in Colorado Springs, Colorado (FEI 1718463) after an inspection that ran Oct 27 – Oct 29, 2021. The investigators were Dogbeda F. Mackenzie and Matthew R. Clabeaux. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
2 of 2 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×) · 211.25(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 02
Employees engaged in the processing and packing of a drug product lack the training required to…
This inspection in context
Dogbeda F. Mackenzie
14 documents · 2021–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in California.
The firmAirgas USA, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
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 quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Airgas USA, LLC?
Dogbeda F. Mackenzie and Matthew R. Clabeaux are named on this Form 483, for the inspection of Oct 27 – Oct 29, 2021. Each investigator has a profile showing what they cite most.
When was Airgas USA, LLC inspected by FDA?
The inspection ran Oct 27 – Oct 29, 2021, and the Form 483 is dated October 29, 2021.
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.