Drug factory · FDA FEI 3001000835
Airgas Usa, LLC
5313 Old Dowd Rd, Charlotte, NC, United States
Problems found, fixed voluntarily at FDA's last inspection, Jun 14, 2018.
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 2018: 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 |
| Nitrous Oxide | Makes it | Airgas USA, LLC | 11054-007 |
| Oxygen | Makes it | Airgas USA, LLC | 11054-009, 11054-010, 11054-110 +2 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jun 14, 2018 | 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.
Jun 14, 2018 inspection
- Written warehousing procedures established/followed 21 CFR 211.142
Procedures describing the warehousing of drug products are not followed.
Registered with FDA for: manufacture.