Drug factory · FDA FEI 3000323524
Nova Laboratories Ltd
Gloucester Cresent, Wigston, United Kingdom
Problems found, fixed voluntarily at FDA's last inspection, Feb 28, 2019.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
3 drug inspections on record since 2013: 0 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Hydroxyurea | Makes it | Nova Laboratories, Ltd. | 62484-0015 |
| Mercaptopurine | Makes it | Nova Laboratories, Ltd. | 62484-0020, 62484-1020 |
| Voretigene Neparvovec | Makes it | Spark Therapeutics, Inc. | 71394-415 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 28, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 3, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 6, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: manufacture.