Drug factory · FDA FEI 3017102
Airgas Usa, LLC
8008 S 222Nd St, Kent, WA, United States
Problems found, fixed voluntarily at FDA's last inspection, Apr 23, 2026.
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 2009: 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 | 11054-006 |
| Oxygen | Makes it | Airgas USA, LLC | 11054-010 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Apr 23, 2026 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 2, 2009 | Problems found, fixed voluntarily | Drug Quality Assurance | 9 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Mar 2, 2009 inspection
- Approval and review of procedures 21 CFR 211.100(a)
Written procedures are not drafted, reviewed and approved by the appropriate organizational units and reviewed and approved by the quality control unit. - Control procedures to monitor and validate performance 21 CFR 211.110(a)
Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product. - Test devices not meeting specifications 21 CFR 211.160(b)(4)
Test devices are deficient in that instruments not meeting established specifications are used. - Record maintenance 1 year (except exempt OTC) 21 CFR 211.180(b)
All records of production associated with a batch of drug product are not maintained at least one (1) year after the expiration date. - Written procedures followed 21 CFR 211.186(a)
Procedures for the preparation of master production and control records are not followed. - Extent of discrepancy, failure investigations 21 CFR 211.192
Investigations of an unexplained discrepancy did not extend to other batches of the same drug product. - Quality control unit review of records 21 CFR 211.192
Drug product production and control records, are not reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed. - Approve or reject procedures or specs 21 CFR 211.22(c)
The quality control unit lacks responsibility to approve and reject all procedures or specifications impacting on the identity, strength, quality, and purity of drug products. - Written calibration / inspection records not kept 21 CFR 211.68(a)
Records of the calibration checks and inspections of automatic, mechanical or electronic equipment, including computers or related systems are not maintained.
Registered with FDA for: manufacture.