Drug factory · FDA FEI 1619686
Airgas Usa, LLC
9607 Knight Rd, Houston, TX, United States
Problems found, fixed voluntarily at FDA's last inspection, Aug 15, 2024.
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 2012: 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 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Aug 15, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Sep 20, 2012 | 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.
Aug 15, 2024 inspection
- Records reviewed annually 21 CFR 211.180(e)
Records are not maintained so that data therein can be reviewed at least annually to evaluate the quality standards of each drug product to determine the need for changes in specifications or manufacturing or control procedures. - Records of disposition of rejected material 21 CFR 211.184(e)
Records do not include the disposition of rejected components, drug product containers and closures.
Registered with FDA for: manufacture.