Drug factory · FDA FEI 1718463
Airgas Usa, LLC
306 S Chestnut St, Colorado Springs, CO, United States
Problems found, fixed voluntarily at FDA's last inspection, Oct 29, 2021.
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 2021: 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 |
|---|---|---|---|
| Oct 29, 2021 | 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.
Oct 29, 2021 inspection
- Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed. - Training , Education , Experience overall 21 CFR 211.25(a)
Employees engaged in the processing and packing of a drug product lack the training required to perform their assigned functions.
Registered with FDA for: manufacture.