Drug factory · FDA FEI 3005674517
Bora Pharmaceutical Laboratories Inc. Zhongli Plant
3-1, Ziqiang 4th 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 |
|---|
| Bethanechol | Makes it and packages it |
Upsher-Smith Laboratories, Inc. |
0832-0510, 0832-0511, 0832-0512 +1 |
| Cyclobenzaprine | Makes it, tests it and packages it |
Upsher-Smith Laboratories, Inc. |
24979-035, 24979-036 |
| Dexlansoprazole | Makes it, tests it and packages it |
Upsher-Smith Laboratories, Inc. |
24979-001, 24979-002 |
| Dicyclomine | Makes it, tests it and packages it |
Upsher-Smith Laboratories, Inc. |
24979-200, 24979-201 |
| Diltiazem | Makes it, tests it and packages it |
Upsher-Smith Laboratories, Inc. |
24979-026, 24979-027, 24979-028 +5 |
| Donepezil | Makes it, tests it and packages it |
Upsher-Smith Laboratories, Inc. |
24979-004 |
| Fluphenazine | Makes it, tests it and packages it |
Upsher-Smith Laboratories, Inc. |
24979-136, 24979-137, 24979-138 +1 |
| Galantamine | Makes it |
Upsher-Smith Laboratories, Inc. |
24979-722, 24979-723, 24979-724 |
| Guanfacine | Makes it, tests it and packages it |
TWi Pharmaceuticals, Inc., Upsher-Smith Laboratories, Inc. |
24979-198, 24979-199, 24979-533 +3 |
| Megestrol | Makes it, tests it and packages it |
Upsher-Smith Laboratories, Inc. |
24979-041 |
| Monomethyl | Makes it and packages it |
Upsher-Smith Laboratories, Inc. |
24979-127, 24979-128 |
| Nifedipine | Makes it and tests it |
Upsher-Smith Laboratories, Inc. |
24979-009, 24979-010, 24979-011 |
| Potassium Cation | Tests it |
Upsher-Smith Laboratories, Inc. |
0245-0835, 0245-0836, 24979-229 +1 |
| Sevelamer | Makes it and tests it |
TWi Pharmaceuticals, Inc. |
24979-186 |
| Terbutaline | Makes it, tests it and packages it |
Upsher-Smith Laboratories, Inc. |
24979-132, 24979-133 |
| Topiramate | Makes it and tests it |
Upsher-Smith Laboratories, Inc. |
24979-210, 24979-211 |
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.