Drug factory · FDA FEI 1522748
Linde Gas & Equipment Inc.
2045 East Aurora Road, Twinsburg, OH, United States
No problems found at FDA's last inspection, Nov 20, 2019.
No Action Indicated: inspectors found no objectionable conditions.
2 drug inspections on record since 2014: 1 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Air | Makes it | Linde Gas & Equipment Inc. | 59579-006 |
| Oxygen | Makes it | Linde Gas & Equipment Inc. | 59579-001 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Nov 20, 2019 | No problems found | Drug Quality Assurance | — |
| Jun 19, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
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 19, 2014 inspection
- Establishment of calibration procedures 21 CFR 211.160(b)(4)
Procedures describing the calibration of instruments, apparatus, gauges and recording devices are deficiently written or followed. - 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 final specifications prior to release.
Registered with FDA for: manufacture.