Airgas USA, LLC
Form 483 issued June 7, 2022 · Tucson, Arizona
- Inspection
- Jun 3 – Jun 7, 2022
- Investigator
- Crystal Monroy
- Observations
- 3
- Pages
- 4
- FEI number
- 2027329
In short: On June 7, 2022, FDA issued a Form 483 with 3 observations to Airgas USA, LLC in Tucson, Arizona (FEI 2027329) after an inspection that ran Jun 3 – Jun 7, 2022. The investigator was Crystal Monroy. Most observations concern quality system and production.
At a glance
Quality system and production account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
Batch production and control records do not include complete labeling control records, including specimens or copies…
- 03
Strict control is not exercised over labeling issued for use in…
This inspection in context
Crystal Monroy
15 documents · 2014–2026
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 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Airgas USA, LLC?
FDA listed 3 observations on this Form 483, mostly about quality system, production and packaging & labeling. The opening words of each observation are shown on this page.
Who inspected Airgas USA, LLC?
Crystal Monroy is named on this Form 483, for the inspection of Jun 3 – Jun 7, 2022. Each investigator has a profile showing what they cite most.
When was Airgas USA, LLC inspected by FDA?
The inspection ran Jun 3 – Jun 7, 2022, and the Form 483 is dated June 7, 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.