Drug factory · FDA FEI 1000137684
Airgas Usa, LLC
806 River Rd, Charlestown, NH, United States
Problems found, fixed voluntarily at FDA's last inspection, Dec 7, 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 2013: 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 |
|---|---|---|---|
| Dec 7, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Nov 5, 2013 | 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.
Dec 7, 2015 inspection
- Calibration - at intervals, written program, remedial action 21 CFR 211.160(b)(4)
The calibration of gauges is not done at suitable intervals in accordance with an established written program . - Prepared for each batch, include complete information 21 CFR 211.188
Batch production and control records do not include complete information relating to the production and control of each batch . - Quality control unit review of records 21 CFR 211.192
Drug product production and control records, are not reviewed by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed.
Nov 5, 2013 inspection
- In-process and laboratory control results 21 CFR 211.188(b)(5)
Batch production and control records do not include in-process results for each batch of drug product produced.
Registered with FDA for: manufacture.