Drug factory · FDA FEI 3004564371
Airgas Usa, LLC
103 Industrial St, Hopewell, VA, United States
Problems found, fixed voluntarily at FDA's last inspection, Feb 5, 2016.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
2 drug inspections on record since 2014: 1 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Carbon Dioxide | Makes it | Airgas Carbonic, Inc. | 63917-001 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 5, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Feb 7, 2014 | No problems found | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Feb 5, 2016 inspection
- Authority lacking to review records, investigate errors 21 CFR 211.22(a)
The quality control unit lacks authority to review production records to assure that no errors have occurred .
Registered with FDA for: manufacture.