Drug factory · FDA FEI 3008294267
Airgas Usa, LLC
7600 Oak Leaf Rd, Oakwood Village, OH, United States
No problems found at FDA's last inspection, Aug 11, 2015.
No Action Indicated: inspectors found no objectionable conditions.
2 drug inspections on record since 2011: 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 | 11054-006 |
| Oxygen | Makes it | Airgas USA, LLC | 11054-110 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Aug 11, 2015 | No problems found | Drug Quality Assurance | — |
| Jul 7, 2011 | 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.
Jul 7, 2011 inspection
- Laboratory equipment calibration records 21 CFR 211.194(d)
Laboratory records do not include complete records of the periodic calibration of laboratory instruments.
Registered with FDA for: manufacture.