Airgas USA, LLC
Form 483 issued July 22, 2022 · Miami, Florida
- Inspection
- Jul 19 – Jul 22, 2022
- Investigator
- Jennifer Lalama
- Observations
- 2
- Pages
- 3
- FEI number
- 1025636
In short: On July 22, 2022, FDA issued a Form 483 with 2 observations to Airgas USA, LLC in Miami, Florida (FEI 1025636) after an inspection that ran Jul 19 – Jul 22, 2022. The investigator was Jennifer Lalama. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.56 (sanitation).
At a glance
Facilities & equipment and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.56(a) (1×) · 211.180(e) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in…
- 02
Records are not maintained so that data therein can be reviewed at least annually to evaluate…
This inspection in context
Jennifer Lalama
31 documents · 2015–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Florida.
The firmAirgas USA, LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.56(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 quality system. The most-cited regulation is 21 CFR 211.56 (sanitation). The opening words of each observation are shown on this page.
Who inspected Airgas USA, LLC?
Jennifer Lalama is named on this Form 483, for the inspection of Jul 19 – Jul 22, 2022. Each investigator has a profile showing what they cite most.
When was Airgas USA, LLC inspected by FDA?
The inspection ran Jul 19 – Jul 22, 2022, and the Form 483 is dated July 22, 2022.
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.