Drug factory · FDA FEI 3003295940
Airgas Usa, LLC
1570 E Riverview Dr, Phoenix, AZ, United States
Problems found, fixed voluntarily at FDA's last inspection, Jun 17, 2021.
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 2015: 1 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Carbon Dioxide | Makes it | Airgas USA, LLC | 11054-130 |
| 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, 11054-110 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jun 17, 2021 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Oct 20, 2015 | 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.
Jun 17, 2021 inspection
- Procedures to be written and followed 21 CFR 211.198(a)
Procedures describing the handling of all written and oral complaints regarding a drug product are not followed. - Complaint Investigation/Follow-Up Findings 21 CFR 211.198(b)(2)
Complaint records are deficient in that they do not include the findings of the investigation.
Registered with FDA for: manufacture.