Drug factory · FDA FEI 3002806909
Dottikon Exclusive Synthesis Ag
Hembrunnstrasse 17, Dottikon, Switzerland
Problems found, fixed voluntarily at FDA's last inspection, Feb 7, 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 2012: 1 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Tiratricol | Makes the active ingredient | Rare Thyroid Therapeutics International AB | 87216-0100 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 7, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 16, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 14, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 11, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 28, 2012 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture.