Drug factory · FDA FEI 1000153019
Bachem AG
Hauptstrasse 144, Bubendorf, Switzerland
Problems found, fixed voluntarily at FDA's last inspection, Aug 16, 2024.
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 2010: 3 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Bivalirudin | Makes the active ingredient | ENDO USA, Inc. | 42023-622 |
| Glucagon | Makes the active ingredient and tests it | Cipla USA., Inc. | 69097-027 |
| Pegcetacoplan | Makes the active ingredient | Apellis Pharmaceuticals, Inc. | 73606-010, 73606-020 |
| Sincalide | Makes the active ingredient | Bracco Diagnostics Inc. | 0270-0556 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Aug 16, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 17, 2017 | No problems found | Drug Quality Assurance | — |
| Feb 14, 2014 | No problems found | Drug Quality Assurance | — |
| Sep 29, 2010 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture.