Drug factory · FDA FEI 2350034
Airgas Usa, LLC
4206 Access Rd, Jonesboro, AR, United States
Problems found, fixed voluntarily at FDA's last inspection, Nov 7, 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 |
|---|---|---|---|
| Nitrogen | Makes it | Airgas USA, LLC | 11054-006 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Nov 7, 2011 | 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.
Nov 7, 2011 inspection
- In-process and laboratory control results 21 CFR 211.188(b)(5)
Batch production and control records do not include laboratory control results for each batch of drug product produced.
Registered with FDA for: manufacture.