Drug factory · FDA FEI 1000350927
Bayer Oy
Pansiontie 47, Turku, Finland
Problems found, fixed voluntarily at FDA's last inspection, Sep 15, 2023.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
5 drug inspections on record since 2010: 2 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Levonorgestrel | Makes it, tests it, packages it, labels it and sterilizes it | Bayer HealthCare Pharmaceuticals Inc. | 50419-423, 50419-424 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Sep 15, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 1, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 15, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 15, 2011 | No problems found | Drug Quality Assurance | — |
| Sep 24, 2010 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; label; manufacture; pack; sterilize.