Drug factory · FDA FEI 1717226
Airgas Usa, LLC
3415 S 700 W, Salt Lake City, UT, United States
Problems found, fixed voluntarily at FDA's last inspection, Dec 16, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
4 drug inspections on record since 2013: 0 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| 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 |
| Nitrous Oxide | Makes it | Airgas USA, LLC | 11054-007 |
| Oxygen | Makes it | Airgas USA, LLC, Uintah Basin Medical Center dba Home Health Equipment and Supply | 11054-009, 11054-010, 11054-110 +3 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Dec 16, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Feb 18, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Oct 25, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Oct 31, 2013 | Problems found, fixed voluntarily | 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.
Dec 16, 2024 inspection
- Lab controls established, including changes 21 CFR 211.160(a)
The establishment of sampling plans including any changes thereto, are not drafted by the appropriate organizational unit and reviewed and approved by the quality control unit. - Calibration/Inspection/Checking not done 21 CFR 211.68(a)
Routine calibration of equipment is not performed according to a written program designed to assure proper performance.
Feb 18, 2022 inspection
- Label storage access limited to authorized personnel 21 CFR 211.122(d)
Access to the storage area for labels and labeling materials is not limited to authorized personnel. - Prevention of cross contamination, mix-ups 21 CFR 211.130(a)
There is insufficient physical or spatial separation from operations and other drug products to prevent mix-ups and cross-contamination.
Oct 25, 2019 inspection
- Absence of Written Procedures 21 CFR 211.100(a)
There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.
Registered with FDA for: manufacture.