Drug factory · FDA FEI 2244047
Airgas Usa, LLC
1 Frassetto Way Ste D, Lincoln Park, NJ, United States
Problems found, fixed voluntarily at FDA's last inspection, Jun 21, 2023.
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: 2 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, Mada Medical Products, Inc. | 11054-009, 11054-010, 11054-110 +1 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jun 21, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Dec 22, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
| Nov 21, 2013 | No problems found | Drug Quality Assurance | — |
| Jan 6, 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.
Jun 21, 2023 inspection
- Distinctive ID or code not recorded in batch record 21 CFR 211.105(b)
The batch records do not record the distinctive code to identify major equipment to show the specific equipment used in the manufacture of a batch of a drug product. - Complete Test Data 21 CFR 211.194(a)(4)
Laboratory records are deficient in that they do not include a complete record of all data obtained during testing. - Procedures to be written and followed 21 CFR 211.198(a)
Procedures describing the handling of all written and oral complaints regarding a drug product are not followed.
Dec 22, 2015 inspection
- Distinctive ID or code not recorded in batch record 21 CFR 211.105(b)
The batch records do not record the distinctive identification number to identify major equipment to show the specific equipment used in the manufacture of a batch of a drug product. - Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that conform to appropriate standards of identity, strength, quality and purity. - Testing and release for distribution 21 CFR 211.165(a)
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the prior to release. - Complete Test Data 21 CFR 211.194(a)(4)
Laboratory records are deficient in that they do not include a complete record of all data obtained during testing.
Registered with FDA for: manufacture.