Drug factory · FDA FEI 3003346516
Biocodex
1 avenue Blaise Pascal, Beauvais, France
Problems found, fixed voluntarily at FDA's last inspection, Jun 17, 2022.
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 2016: 1 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Stiripentol | Makes it | Biocodex, Inc. | 68418-7939, 68418-7940, 68418-7941 +1 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jun 17, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jan 23, 2020 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 16, 2016 | No problems found | Bioresearch Monitoring | — |
Registered with FDA for: analysis; api manufacture; label; manufacture; pack; relabel; repack.