Drug factory · FDA FEI 3020693
Linde Gas & Equipment Inc.
480 E 19th St, Tacoma, WA, United States
No problems found at FDA's last inspection, Apr 8, 2014.
No Action Indicated: inspectors found no objectionable conditions.
3 drug inspections on record since 2009: 2 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 |
| Carbon Dioxide | Makes it | Linde Gas & Equipment Inc. | 59579-003 |
| Nitrogen | Makes it | Linde Gas & Equipment Inc. | 59579-002 |
| Nitrous Oxide | Makes it | Linde Gas & Equipment Inc. | 59579-004 |
| Oxygen | Makes it | Linde Gas & Equipment Inc. | 59579-001 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Apr 8, 2014 | No problems found | Drug Quality Assurance | — |
| Dec 1, 2011 | No problems found | Drug Quality Assurance | — |
| Dec 3, 2009 | 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.
Dec 3, 2009 inspection
- Quarantine - actual practice 21 CFR 211.142(a)
Drug products are not quarantined before being released by the quality control unit. - Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not fully followed.
Registered with FDA for: manufacture.