Drug factory · FDA FEI 3002808292
Swiss Caps AG
Husenstrasse 35, Kirchberg, Switzerland
Problems found, fixed voluntarily at FDA's last inspection, Jun 29, 2023.
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 |
|---|---|---|---|
| Benzonatate | Makes it | Alembic Pharmaceuticals Inc. | 62332-426, 62332-427 |
| Ergocalciferol | Makes it | Alembic Pharmaceuticals Inc. | 62332-464 |
| Ethosuximide | Makes it | Akorn | 61748-025 |
| Isotretinoin | Makes it | Akorn | 61748-301, 61748-302, 61748-303 +1 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jun 29, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 27, 2019 | No problems found | Drug Quality Assurance | — |
| Jun 16, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
| Oct 31, 2014 | No problems found | Drug Quality Assurance | — |
| Nov 23, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Nov 25, 2010 | 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.
Jun 16, 2017 inspection
- Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures designed to assure that components and in-process materials conform to appropriate standards of identity, strength, quality and purity. - Test methods 21 CFR 211.165(e)
The accuracy, sensitivity and reproducibility of test methods have not been established and documented. - No written record of investigation 21 CFR 211.192
Written records are not always made of investigations into unexplained discrepancies and the failure of a batch or any of its components to meet specifications. - Backup data not assured as exact and complete 21 CFR 211.68(b)
Backup data is not assured as exact, complete and secure from alteration, erasure or loss through keeping hard copy or alternate systems.
Nov 23, 2012 inspection
- Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
Registered with FDA for: manufacture.