Drug factory · FDA FEI 1317232
Airgas Usa, LLC
3650 Broadway St, Cheektowaga, NY, United States
Problems found, fixed voluntarily at FDA's last inspection, Feb 23, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
3 drug inspections on record since 2012: 1 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, 11054-010 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 23, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | 5 |
| Aug 28, 2013 | No problems found | Drug Quality Assurance | — |
| Mar 23, 2012 | 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.
Feb 23, 2024 inspection
- Strict control not exercised over labeling issued 21 CFR 211.125(a)
Strict control is not exercised over labeling issued for use in drug product labeling operations. - Calibration - at intervals, written program, remedial action 21 CFR 211.160(b)(4)
The calibration of instruments is not done at suitable intervals in accordance with an established written program. - Items to cover on annual reviews 21 CFR 211.180(e)(2)
Written procedures are not established for evaluations done at least annually and including provisions for a review of complaints, recalls and returned or salvaged drug products. - Labeling control records including specimens or copies 21 CFR 211.188(b)(8)
Batch production and control records do not include complete labeling control records, including specimens or copies of all labeling used for each batch of drug product produced. - Calibration/Inspection/Checking not done 21 CFR 211.68(a)
Routine inspection and checking of mechanical and electronic equipment is not performed according to a written program designed to assure proper performance.
Mar 23, 2012 inspection
- SOPs not followed / documented 21 CFR 211.100(b)
Written production and process control procedures are not followed in the execution of production and process control functions.
Registered with FDA for: manufacture.