Drug factory · FDA FEI 2911065
Airgas Usa, LLC
3970 Wilcox Rd, Stockton, CA, United States
Problems found, fixed voluntarily at FDA's last inspection, Sep 23, 2011.
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 2011: 0 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Oxygen | Makes it | Airgas USA, LLC | 11054-009 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Sep 23, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
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 23, 2011 inspection
- Written warehousing procedures established/followed 21 CFR 211.142
Procedures describing the warehousing of drug products are not established and followed. - Returned drug products identified and held 21 CFR 211.204
Returned drug products are not identified as such and held.
Registered with FDA for: manufacture.