Drug factory · FDA FEI 3002627102
Airgas Usa, LLC
9225 Sibley Hole Rd, Little Rock, AR, United States
Problems found, fixed voluntarily at FDA's last inspection, Mar 1, 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 |
|---|---|---|---|
| Nitrogen | Makes it | Airgas USA, LLC | 11054-005, 11054-006 |
| Oxygen | Makes it | Airgas USA, LLC | 11054-009, 11054-010 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 1, 2012 | 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.
Mar 1, 2012 inspection
- Written procedures followed 21 CFR 211.186(a)
Procedures for the preparation of master production and control records are not followed. - Stability testing records not included 21 CFR 211.194(e)
Laboratory records do not include complete records of all stability testing performed.
Registered with FDA for: manufacture.