Drug factory · FDA FEI 3002806821
N.V. Organon
Kloosterstraat 6, Oss, Netherlands
No problems found at FDA's last inspection, Sep 8, 2022.
No Action Indicated: inspectors found no objectionable conditions.
11 drug inspections on record since 2009: 7 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Norethindrone | Makes the active ingredient | Ohm Laboratories Inc. | 51660-127 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Sep 8, 2022 | No problems found | Drug Quality Assurance | — |
| Aug 25, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 20, 2019 | No problems found | Drug Quality Assurance | — |
| Sep 10, 2019 | No problems found | Drug Quality Assurance | — |
| Sep 7, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 8, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 7, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 5, 2013 | No problems found | Drug Quality Assurance | — |
| Oct 26, 2012 | No problems found | Drug Quality Assurance | — |
| Jul 2, 2010 | No problems found | Drug Quality Assurance | — |
| May 14, 2009 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture; label; manufacture; pack; sterilize.