Drug factory · FDA FEI 3006363591
Airgas Usa, LLC
10031 Cincinnati Dayton Pike, Cincinnati, OH, United States
Problems found, fixed voluntarily at FDA's last inspection, Apr 11, 2013.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
1 drug inspection on record since 2013: 0 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 |
| Oxygen | Makes it | Airgas USA, LLC | 11054-009, 11054-010, 11054-110 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Apr 11, 2013 | 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.
Apr 11, 2013 inspection
- Extent of discrepancy, failure investigations 21 CFR 211.192
Investigations of an unexplained discrepancy did not extend to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy.
Registered with FDA for: manufacture.