Drug factory · FDA FEI 3001238930
Airgas Usa, LLC
2700 Boulevard Of Champions, Sioux City, IA, United States
Problems found, fixed voluntarily at FDA's last inspection, Oct 16, 2015.
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 2015: 0 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 |
| Oxygen | Makes it | Airgas USA, LLC | 11054-009, 11054-010 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Oct 16, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Oct 16, 2015 inspection
- Records not kept for each shipment 21 CFR 211.122(c)
Records are not maintained for each shipment received of each different labeling and packaging material. - Destruction of obsolete labeling 21 CFR 211.122(e)
Obsolete or outdated labels, labeling and packaging materials are not destroyed. - Labeling control records including specimens or copies 21 CFR 211.188(b)(8)
Batch production and control records do not include complete labeling control records, including specimens or copies of all labeling used for each batch of drug product produced.
Registered with FDA for: manufacture.