Airgas USA, LLC
Form 483 issued March 2, 2021 · Fort Collins, Colorado
- Inspection
- Feb 23 – Mar 2, 2021
- Observations
- 4
- Pages
- 2
- FEI number
- 3004070098
In short: On March 2, 2021, FDA issued a Form 483 with 4 observations to Airgas USA, LLC in Fort Collins, Colorado (FEI 3004070098) after an inspection that ran Feb 23 – Mar 2, 2021. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.25 (personnel qualifications).
At a glance
3 of 4 observations on this 483 concern quality system.
Most cited: 21 CFR 211.25(a) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Drug product production and control records, are not reviewed and approved by the quality control unit…
- 02
Employees engaged in the manufacture, processing, packing and holding of a drug product lack the training…
- 03
GMP training is not conducted on a continuing basis and with sufficient frequency to assure that…
- 04
Routine calibration of mechanical and electronic equipment is not performed according to a written program designed…
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 and facilities & equipment. The most-cited regulation is 21 CFR 211.25 (personnel qualifications). The opening words of each observation are shown on this page.
When was Airgas USA, LLC inspected by FDA?
The inspection ran Feb 23 – Mar 2, 2021, and the Form 483 is dated March 2, 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.