Drug factory · FDA FEI 2523408
Linde Gas & Equipment Inc.
1 Steel Rd E, Morrisville, PA, United States
Problems found, fixed voluntarily at FDA's last inspection, Apr 1, 2026.
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 2010: 0 with no problems, 2 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 |
| Helium and Oxygen | Makes it | Linde Gas & Equipment Inc. | 59579-009 |
| 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 1, 2026 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 29, 2010 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
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 29, 2010 inspection
- Calibration/Inspection/Checking not done 21 CFR 211.68(a)
Routine calibration of mechanical equipment is not performed according to a written program designed to assure proper performance.
Registered with FDA for: manufacture.