Drug factory · FDA FEI 1000208816
Linde Puerto Rico B.V.
Carr 189 Int 931 Bo. Navarro, Gurabo, PR, United States
No problems found at FDA's last inspection, Nov 17, 2023.
No Action Indicated: inspectors found no objectionable conditions.
3 drug inspections on record since 2013: 1 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Carbon Dioxide | Makes it | Linde Puerto Rico B.V. | 11324-003 |
| Helium | Makes it | Linde Puerto Rico B.V. | 11324-005 |
| Nitrogen | Makes it | Linde Puerto Rico B.V. | 11324-002 |
| Oxygen | Makes it | Linde Puerto Rico B.V. | 11324-001, 11324-006 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Nov 17, 2023 | No problems found | Drug Quality Assurance | — |
| Feb 1, 2013 | Problems found, fixed voluntarily | Unapproved and Misbranded Drugs | — |
| Feb 1, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: manufacture.