Drug factory · FDA FEI 3002808158
Siegfried AG
Untere Bruhlstrasse 4, Zofingen, Switzerland
Problems found, fixed voluntarily at FDA's last inspection, Feb 14, 2025.
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 2010: 3 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Buprenorphine and Naloxone | Makes the active ingredient and tests it | Indivior Inc. | 12496-1202, 12496-1204, 12496-1208 +1 |
| Carbamoylcholine | Makes the active ingredient | Alcon Laboratories, Inc. | 0065-0023 |
| Solriamfetol | Makes the active ingredient | Axsome Therapeutics, Inc. | 81968-350, 81968-351 |
| Topiramate | Makes the active ingredient and tests it | Janssen Pharmaceuticals, Inc. | 50458-639, 50458-640, 50458-641 +3 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 14, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 14, 2019 | No problems found | Drug Quality Assurance | — |
| Jan 27, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 6, 2014 | No problems found | Drug Quality Assurance | — |
| Jun 21, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 29, 2010 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture.