AIRGAS USA, LLC
Form 483 issued March 11, 2022 · San Diego, California
- Inspection
- Mar 7 – Mar 11, 2022
- Observations
- 4
- Pages
- 6
- FEI number
- 2015545
In short: On March 11, 2022, FDA issued a Form 483 with 4 observations to AIRGAS USA, LLC in San Diego, California (FEI 2015545) after an inspection that ran Mar 7 – Mar 11, 2022. Most observations concern quality system and packaging & labeling.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observation- 01
The quality control unit lacks authority to fully investigate…
- 02
Strict control is not exercised over labeling issued for use in…
- 03
Batch production and control records do not include complete information relating to the production and…
- 04
Equipment used in the manufacture, processing, packing or holding of drug products is not to facilitate…
This inspection in context
Questions about this 483
What did FDA find at AIRGAS USA, LLC?
FDA listed 4 observations on this Form 483, mostly about quality system, packaging & labeling and production. The opening words of each observation are shown on this page.
When was AIRGAS USA, LLC inspected by FDA?
The inspection ran Mar 7 – Mar 11, 2022, and the Form 483 is dated March 11, 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.