Drug factory · FDA FEI 1216783
Airgas Usa, LLC
17 Northwestern Dr, Salem, NH, United States
Problems found, fixed voluntarily at FDA's last inspection, Jan 12, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
4 drug inspections on record since 2012: 3 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, 11054-114 +1 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jan 12, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Apr 28, 2014 | No problems found | Drug Quality Assurance | — |
| Oct 23, 2013 | No problems found | Drug Quality Assurance | — |
| Jun 8, 2012 | 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.
Jan 12, 2024 inspection
- Computer control of master formula records 21 CFR 211.68(b)
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
Registered with FDA for: manufacture.