Drug factory · FDA FEI 3008735083
Solvias AG
Römerpark 2, Kaiseraugst, Switzerland
Problems found, fixed voluntarily at FDA's last inspection, Aug 7, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
10 drug inspections on record since 2008: 4 with no problems, 6 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Brigatinib | Tests it | Takeda Pharmaceuticals America, Inc. | 63020-090, 63020-113, 63020-180 +1 |
| Deferoxamine | Tests it | Mitem Pharma | 87081-467 |
| Maribavir | Tests it | Takeda Pharmaceuticals America, Inc. | 64764-800 |
| Plazomicin | Tests it | Achaogen, Inc., Cipla Therapeutics Inc., Cipla USA., Inc. | 71045-010, 80735-820, 69097-820 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Aug 7, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 1, 2023 | Problems found, fixed voluntarily | Bioresearch Monitoring | — |
| Jun 9, 2023 | No problems found | Drug Quality Assurance | — |
| Nov 22, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Oct 27, 2017 | No problems found | Drug Quality Assurance | — |
| Mar 7, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 4, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 8, 2011 | No problems found | Drug Quality Assurance | — |
| Jun 24, 2010 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 4, 2008 | No problems found | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Nov 22, 2022 inspection
- Calibration - at intervals, written program, remedial action 21 CFR 211.160(b)(4)
The calibration of instruments is not done at suitable intervals in accordance with an established written program. - Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
Registered with FDA for: analysis.