AIRGAS USA, LLC
Form 483 issued November 4, 2021 · Oklahoma City, Oklahoma
- Inspection
- Nov 1 – Nov 4, 2021
- Investigators
- Margaret M. Annes· Preston B. Hoover
- Observations
- 3
- Pages
- 3
- FEI number
- 1650151
In short: On November 4, 2021, FDA issued a Form 483 with 3 observations to AIRGAS USA, LLC in Oklahoma City, Oklahoma (FEI 1650151) after an inspection that ran Nov 1 – Nov 4, 2021. The investigators were Margaret M. Annes and Preston B. Hoover. Most observations concern quality system and laboratory controls.
At a glance
2 of 3 observations on this 483 concern quality system.
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 manufacture, processing, packing and holding of a drug product lack the training…
- 03
Established sampling plans and test…
This inspection in context
Margaret M. Annes
60 documents · 2007–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Texas.
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 3 observations on this Form 483, mostly about quality system and laboratory controls. The opening words of each observation are shown on this page.
Who inspected AIRGAS USA, LLC?
Margaret M. Annes and Preston B. Hoover are named on this Form 483, for the inspection of Nov 1 – Nov 4, 2021. Each investigator has a profile showing what they cite most.
When was AIRGAS USA, LLC inspected by FDA?
The inspection ran Nov 1 – Nov 4, 2021, and the Form 483 is dated November 4, 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.