Drug factory · FDA FEI 3008290251
Airgas Usa, LLC
1264 1St Ave, Harvey, LA, United States
Problems found, fixed voluntarily at FDA's last inspection, Feb 22, 2011.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
1 drug inspection on record since 2011: 0 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 |
| Oxygen | Makes it | Airgas USA, LLC | 11054-009 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 22, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
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 22, 2011 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. - Lack of written stability program 21 CFR 211.166(a)
There is no written testing program designed to assess the stability characteristics 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.