Drug factory · FDA FEI 3005674517
Bora Pharmaceutical Laboratories Inc. Zhongli Plant Building II
17, Dongyuan Rd., Zhongli Dist., Taoyuan City, Taiwan
Problems found, fixed voluntarily at FDA's last inspection, Feb 7, 2020.
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 2012: 2 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Cyclobenzaprine | Makes it, tests it and packages it | Upsher-Smith Laboratories, Inc. | 24979-035, 24979-036 |
| Megestrol | Makes it, tests it and packages it | Upsher-Smith Laboratories, Inc. | 24979-041 |
| Monomethyl | Makes it, tests it and packages it | Upsher-Smith Laboratories, Inc. | 24979-127, 24979-128 |
| Sorafenib | Makes it | Upsher-Smith Laboratories, Inc. | 24979-715 |
| Testosterone | Makes it, tests it and packages it | Upsher-Smith Laboratories, Inc. | 24979-078 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 7, 2020 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 7, 2020 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 13, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 13, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 15, 2014 | No problems found | Drug Quality Assurance | — |
| May 15, 2014 | No problems found | Drug Quality Assurance | — |
| Sep 14, 2012 | No problems found | Drug Quality Assurance | — |
| Sep 14, 2012 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; manufacture; pack.