Drug factory · FDA FEI 1111563
Airgas Usa, LLC
608 Nursery Rd, Linthicum Heights, MD, United States
Problems found, fixed voluntarily at FDA's last inspection, Jul 27, 2023.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
2 drug inspections on record since 2013: 1 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 | 11054-005, 11054-006 |
| Nitrous Oxide | Makes it | Airgas USA, LLC | 11054-007 |
| Oxygen | Makes it | Airgas USA, LLC | 11054-009, 11054-010, 11054-114 +1 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jul 27, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Sep 13, 2013 | 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.
Jul 27, 2023 inspection
- 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. - Calibration/Inspection/Checking not done 21 CFR 211.68(a)
Routine inspection and checking of mechanical and electronic equipment is not performed according to a written program designed to assure proper performance.
Registered with FDA for: manufacture.