Drug factory · FDA FEI 1650151
Airgas Usa, LLC
7248 Sw 29Th St, Oklahoma City, OK, United States
Problems found, fixed voluntarily at FDA's last inspection, Nov 4, 2021.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
3 drug inspections on record since 2014: 2 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Nitrogen | Makes it | Airgas USA, LLC | 11054-006 |
| Oxygen | Makes it | Airgas USA, LLC, Anesthesia Service, Inc. | 11054-010, 19218-0001, 19218-0002 +7 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Nov 4, 2021 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Jan 8, 2020 | No problems found | Drug Quality Assurance | — |
| Jan 31, 2014 | No problems found | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Nov 4, 2021 inspection
- Following/documenting laboratory controls 21 CFR 211.160(a)
Established sampling plans and test procedures are not followed. - Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed. - Training , Education , Experience overall 21 CFR 211.25(a)
Employees engaged in the manufacture, processing, packing and holding of a drug product lack the training required to perform their assigned functions.
Registered with FDA for: manufacture.