Drug factory · FDA FEI 2025972
Airgas Usa, LLC
205 Tank Farm Rd, San Luis Obispo, CA, United States
Problems found, fixed voluntarily at FDA's last inspection, Mar 9, 2023.
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 2023: 0 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 USA, LLC | 11054-130 |
| 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 9, 2023 | 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.
Mar 9, 2023 inspection
- Calibration/Inspection/Checking not done 21 CFR 211.68(a)
Routine calibration of automatic, mechanical and electronic equipment is not performed according to a written program designed to assure proper performance.
Registered with FDA for: manufacture.