Drug factory · FDA FEI 3004899646
Airgas Usa, LLC
7007 N Courtenay Pkwy, Merritt Island, FL, United States
Problems found, fixed voluntarily at FDA's last inspection, Sep 2, 2009.
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 2009: 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 | 11054-006 |
| Oxygen | Makes it | Airgas USA, LLC | 11054-010 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Sep 2, 2009 | 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.
Sep 2, 2009 inspection
- Establishment of time limitations 21 CFR 211.111
Time limits are not established when appropriate for the completion of each production phase to assure the quality of the drug product.
Registered with FDA for: manufacture.