Drug factory · FDA FEI 3007704654
Particle Analytical ApS
Agern Alle 3, Hoersholm, Denmark
Problems found, fixed voluntarily at FDA's last inspection, Jan 9, 2025.
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 2009: 4 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Remimazolam | Tests it | Acacia Pharma, Ltd. | 71390-011 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jan 9, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 19, 2021 | No problems found | Drug Quality Assurance | — |
| Sep 27, 2018 | No problems found | Drug Quality Assurance | — |
| Jul 20, 2015 | No problems found | Drug Quality Assurance | — |
| Sep 14, 2009 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis.