Drug factory · FDA FEI 3010164251
Genvion Corporation
500 Camiel Sys Street, Winnipeg, Canada
Problems found, fixed voluntarily at FDA's last inspection, Jul 28, 2023.
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 2016: 1 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Efavirenz and Emtricitabine and Tenofovir | Makes it, tests it, packages it and labels it | Cipla USA., Inc., Exelan Pharmaceuticals, Inc. | 69097-210, 76282-678 |
| Lanthanum Cation (3+) | Makes it and packages it | Cipla USA., Inc., Exelan Pharmaceuticals, Inc. | 69097-934, 69097-935, 69097-936 +3 |
| Lenalidomide | Makes it, tests it, packages it and labels it | Cipla USA., Inc., Exelan Pharmaceuticals, Inc. | 69097-381, 69097-382, 69097-383 +9 |
| Nilotinib | Makes it and tests it | Cipla USA., Inc. | 69097-030, 69097-031, 69097-032 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jul 28, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 17, 2016 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; label; manufacture; pack; particle size reduction; relabel; repack.