Drug factory · FDA FEI 1000150771
Linde Gas & Equipment Inc.
601 W Sunset Road, Henderson, NV, United States
Problems found, fixed voluntarily at FDA's last inspection, Mar 4, 2015.
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 2015: 0 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 |
|---|---|---|---|
| Mar 4, 2015 | 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.
Mar 4, 2015 inspection
- Quality control operations - components, packaging, labels 21 CFR 111.120
You do not have quality control operations for packaging and labels before use in the manufacture of a dietary supplement. - Personnel - records - training 21 CFR 111.14(b)(2)
You did not make and keep documentation of training. - Written record of investigation incomplete 21 CFR 211.192
Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up.
Registered with FDA for: manufacture.