Drug factory · FDA FEI 1000516326
Airgas Usa, LLC
5001 E Broadway St, North Little Rock, AR, United States
No problems found at FDA's last inspection, Feb 5, 2013.
No Action Indicated: inspectors found no objectionable conditions.
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 |
|---|---|---|---|
| Carbon Dioxide | Makes it | Airgas USA, LLC | 11054-130 |
| Nitrogen | Makes it | Airgas USA, LLC | 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 |
|---|---|---|---|
| Feb 5, 2013 | No problems found | Drug Quality Assurance | — |
| Aug 29, 2012 | 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.
Aug 29, 2012 inspection
- Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not fully followed.
Registered with FDA for: manufacture.