Airgas USA, LLC
Form 483 issued June 21, 2023 · Lincoln Park, New Jersey
- Inspection
- Jun 21, 2023
- Observations
- 3
- Pages
- 4
- FEI number
- 2244047
In short: On June 21, 2023, FDA issued a Form 483 with 3 observations to Airgas USA, LLC in Lincoln Park, New Jersey (FEI 2244047) after an inspection that ran Jun 21, 2023. Most observations concern laboratory controls and quality system.
At a glance
Laboratory controls and quality system account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
Laboratory records are deficient in that they do not include a complete record of all…
- 02
Procedures describing the handling of all written and oral complaints regarding a drug…
- 03
The batch records do not record the distinctive code to identify major equipment to show the…
This inspection in context
Questions about this 483
What did FDA find at Airgas USA, LLC?
FDA listed 3 observations on this Form 483, mostly about laboratory controls, quality system and production. The opening words of each observation are shown on this page.
When was Airgas USA, LLC inspected by FDA?
The inspection ran Jun 21, 2023, and the Form 483 is dated June 21, 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.