Drug factory · FDA FEI 3002807111
Sterigenics Belgium (Petit Rechain) SRL
Avenue Andre Ernst 21, Verviers, Belgium
Problems found, fixed voluntarily at FDA's last inspection, Jun 29, 2023.
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 2014: 2 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Aflibercept | Sterilizes it | CELLTRION USA, Inc. | 72606-026 |
| Levonorgestrel | Sterilizes it | Bayer HealthCare Pharmaceuticals Inc. | 50419-423, 50419-424 |
| Methylprednisolone | Sterilizes it | Pharmacia & Upjohn Company LLC | 0009-3073, 0009-3475 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jun 29, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 10, 2016 | No problems found | Drug Quality Assurance | — |
| Sep 16, 2014 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; sterilize.