Airgas USA, LLC
Form 483 issued October 18, 2019 · Miami, Florida
- Inspection
- Oct 16 – Oct 18, 2019
- Investigators
- Joanne E. King· Vivin George
- Observations
- 5
- Pages
- 4
- FEI number
- 1025636
In short: On October 18, 2019, FDA issued a Form 483 with 5 observations to Airgas USA, LLC in Miami, Florida (FEI 1025636) after an inspection that ran Oct 16 – Oct 18, 2019. The investigators were Joanne E. King and Vivin George. Most observations concern production and facilities & equipment.
At a glance
Production and facilities & equipment account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
Equipment used in the manufacture, processing, packing or holding of drug products is not suitably located…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 03
Master production and control records lack complete manufacturing and control instructions, sampling and…
- 04
Batch production and control records do not include the identification of the persons performing and checking…
This inspection in context
Joanne E. King
34 documents · 2013–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Florida.
The firmAirgas USA, LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.63
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Airgas USA, LLC?
FDA listed 5 observations on this Form 483, mostly about production, facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Airgas USA, LLC?
Joanne E. King and Vivin George are named on this Form 483, for the inspection of Oct 16 – Oct 18, 2019. Each investigator has a profile showing what they cite most.
When was Airgas USA, LLC inspected by FDA?
The inspection ran Oct 16 – Oct 18, 2019, and the Form 483 is dated October 18, 2019.
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.