Drug factory · FDA FEI 3010414279
Aspen Oss B.V.
Veersemeer 4, Oss, Netherlands
Problems found, fixed voluntarily at FDA's last inspection, Nov 24, 2022.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
6 drug inspections on record since 2014: 1 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Drospirenone and Ethinyl Estradiol | Makes the active ingredient | Xiromed, LLC. | 70700-114 |
| Ethinyl Estradiol and Levonorgestrel | Makes the active ingredient | Xiromed, LLC. | 70700-116, 70700-117 |
| Ethinyl Estradiol and Norgestimate | Makes the active ingredient | Xiromed, LLC. | 70700-121 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Nov 24, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 24, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 13, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 13, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 25, 2014 | No problems found | Drug Quality Assurance | — |
| Sep 25, 2014 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture; manufacture; pack; sterilize.