Drug factory · FDA FEI 3004654486
Airgas Usa, LLC
522 Jefferson Blvd, Warwick, RI, United States
Problems found, fixed voluntarily at FDA's last inspection, Feb 26, 2014.
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: 1 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 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 26, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Nov 3, 2011 | 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.
Feb 26, 2014 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. - Adverse Drug Experience 21 CFR 211.198(a)
Complaint procedures are deficient in that they do not include provisions that allow for the review to determine if the complaints represent serious and unexpected adverse drug experiences which are required to be reported to FDA. - Returned drug procedures in writing and followed 21 CFR 211.204
Procedures describing the holding and testing of returned drug products are not in writing.
Registered with FDA for: manufacture.