Drug factory · FDA FEI 2027329
Airgas Usa, LLC
727 E Evans Blvd, Tucson, AZ, United States
Problems found, fixed voluntarily at FDA's last inspection, Jun 7, 2022.
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 2020: 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 |
| Oxygen | Makes it | Airgas USA, LLC | 11054-009, 11054-010 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jun 7, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Jan 7, 2020 | 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.
Jun 7, 2022 inspection
- Strict control not exercised over labeling issued 21 CFR 211.125(a)
Strict control is not exercised over labeling issued for use in drug product labeling operations. - 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. - 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.