Drug factory · FDA FEI 3003714586
Airgas Usa, LLC
5373 Auto Center Way Ste 101, Bremerton, WA, United States
Problems found, fixed voluntarily at FDA's last inspection, Jul 20, 2012.
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 2012: 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 | 11054-010 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jul 20, 2012 | 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.
Jul 20, 2012 inspection
- SOPs not followed / documented 21 CFR 211.100(b)
Written production and process control procedures are not documented at the time of performance.
Registered with FDA for: manufacture.