Drug factory · FDA FEI 3005128756
Linde Gas & Equipment Inc.
449 Rolling Meadows Drive, Fon Du Lac, WI, United States
Problems found, fixed voluntarily at FDA's last inspection, Jan 22, 2016.
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 2012: 1 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Oxygen | Makes it | Linde Gas & Equipment Inc. | 59579-001 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jan 22, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Jun 29, 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.
Jan 22, 2016 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 .
Registered with FDA for: manufacture.