Drug factory · FDA FEI 1000119390
Cambrex Charles City, Inc
1205 11th Street, Charles City, IA, United States
Problems found, fixed voluntarily at FDA's last inspection, Mar 7, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
8 drug inspections on record since 2008: 5 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Amphetamine and Dextroamphetamine | Makes the active ingredient, tests it and packages it | Global Pharmaceuticals, Division of Impax Laboratories Inc., Prasco Laboratories, Sandoz Inc., Takeda Pharmaceuticals America, Inc. | 0115-1328, 0115-1329, 0115-1330 +25 |
| Camizestrant | Makes the active ingredient | AstraZeneca Pharmaceuticals LP | 0310-0075 |
| Dextroamphetamine | Makes the active ingredient | Amneal Pharmaceuticals | 0115-9927, 0115-9928, 0115-9929 |
| Lisdexamfetamine | Makes the active ingredient | Takeda Pharmaceuticals America, Inc. | 59417-101, 59417-102, 59417-103 +10 |
| Thiosulfate Ion | Makes the active ingredient | Fennec Pharmaceuticals Inc. | 73077-010 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 7, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 2, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 22, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 27, 2014 | No problems found | Drug Quality Assurance | — |
| Aug 2, 2013 | No problems found | Drug Quality Assurance | — |
| Feb 28, 2012 | No problems found | Drug Quality Assurance | — |
| Mar 26, 2010 | No problems found | Drug Quality Assurance | — |
| Oct 8, 2008 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture.