Drug factory · FDA FEI 1212420
Airgas Usa, LLC
325 McCausland Ct, Cheshire, CT, United States
Problems found, fixed voluntarily at FDA's last inspection, Jan 14, 2015.
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 2011: 0 with no problems, 2 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, 11054-110 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jan 14, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 10, 2011 | 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.
May 10, 2011 inspection
- Label reconciliation discrepancies evaluation/investigation 21 CFR 211.125(c)
Discrepancies found outside preset limits when reconciling the quantities of labeling issued, used and returned, were not evaluated and investigated. - Procedures Written and Followed 21 CFR 211.125(f)
Procedures describing in sufficient detail the controls employed for the issuance of labeling are not followed.
Registered with FDA for: manufacture.