AIRGAS USA, LLC
Form 483 issued July 27, 2023 · Linthicum Heights, Maryland
- Inspection
- Jul 27, 2023
- Investigator
- David A. Oluwo
- Observations
- 2
- Pages
- 3
- FEI number
- 1111563
In short: On July 27, 2023, FDA issued a Form 483 with 2 observations to AIRGAS USA, LLC in Linthicum Heights, Maryland (FEI 1111563) after an inspection that ran Jul 27, 2023. The investigator was David A. Oluwo. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Facilities & equipment and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.68(a) (1×) · 211.192 (1×)
What FDA observed
Preview: the opening words of each observation- 01
Routine inspection and checking of mechanical and electronic equipment is not performed according to a written…
- 02
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
This inspection in context
David A. Oluwo
27 documents · 2017–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Maryland.
The firmAIRGAS USA, LLC history
The site's inspection history, in date order.
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 quality system. 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?
David A. Oluwo is named on this Form 483, for the inspection of Jul 27, 2023. Each investigator has a profile showing what they cite most.
When was AIRGAS USA, LLC inspected by FDA?
The inspection ran Jul 27, 2023, and the Form 483 is dated July 27, 2023.
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.