Drug factory · FDA FEI 3006272184
Vistin Pharma AS avd Kragerø Fikkjebakke
Kragerø Næringspark Stuttlidalen 4, Sannidal, Norway
Problems found, fixed voluntarily at FDA's last inspection, Jan 31, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
4 drug inspections on record since 2011: 0 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Linagliptin and Metformin | Makes the active ingredient | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0146, 0597-0147, 0597-0148 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jan 31, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 24, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 4, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 7, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture; manufacture.