Drug factory · FDA FEI 3002806598
Bidachem S.p.a.
Strada Statale 11 (Padana Superiore), 8, Fornovo S. Giovanni (BG), Italy
Problems found, fixed voluntarily at FDA's last inspection, May 17, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
7 drug inspections on record since 2009: 5 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Dabigatran | Makes the active ingredient and tests it | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0108, 0597-0355, 0597-0360 +6 |
| Linagliptin | Makes the active ingredient | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0140 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| May 17, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 23, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 18, 2018 | No problems found | Drug Quality Assurance | — |
| Jun 2, 2016 | No problems found | Drug Quality Assurance | — |
| Jul 17, 2013 | No problems found | Drug Quality Assurance | — |
| Sep 14, 2012 | No problems found | Drug Quality Assurance | — |
| Jul 24, 2009 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture.