Drug factory · FDA FEI 2023613
Airgas Usa, LLC
1340 E Mission Blvd, Pomona, CA, United States
No problems found at FDA's last inspection, Nov 17, 2022.
No Action Indicated: inspectors found no objectionable conditions.
3 drug inspections on record since 2017: 2 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 |
| Helium | Makes it | Airgas USA, LLC | 11054-004 |
| Helium and Oxygen | Makes it | Airgas USA, LLC | 11054-032, 11054-041, 11054-042 |
| Nitrogen | Makes it | Airgas USA, LLC | 11054-005, 11054-006 |
| Oxygen | Makes it | Airgas USA, LLC | 11054-009, 11054-010, 11054-114 +1 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Nov 17, 2022 | No problems found | Drug Quality Assurance | — |
| Oct 18, 2019 | No problems found | Drug Quality Assurance | — |
| Oct 18, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Oct 18, 2017 inspection
- SOPs not followed / documented 21 CFR 211.100(b)
Written production and process control procedures are not documented at the time of performance.
Registered with FDA for: manufacture.