Home / Taiwan / Bora Pharmaceutical Laboratories Inc.
Drug factory · FDA FEI 3007184570
Bora Pharmaceutical Laboratories Inc.
No. 1, Kedong 3rd Rd., Hsinchu Science Park, Zhunan Township, Taiwan
Taiwan: 1
Problems found, fixed voluntarily at FDA's last inspection, Jul 21, 2025.
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: 3 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
Drug Role For NDC
Carbidopa and Levodopa Makes it, tests it, packages it and labels it
Amneal Pharmaceuticals , Zydus Pharmaceuticals (USA) Inc. 64896-661 , 64896-662 , 64896-663 +5Chlorpromazine Makes it
Upsher-Smith Laboratories, Inc. 0832-6017 , 0832-6018 , 0832-6019 +2Cyclobenzaprine 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 Packages it
Upsher-Smith Laboratories, Inc. 24979-026 , 24979-027 , 24979-028 +5Donepezil Packages it
Upsher-Smith Laboratories, Inc. 24979-004 Doxycycline Makes it, tests it, packages it and labels it
Amneal Pharmaceuticals 0115-1327 Fenofibric Acid Makes it, tests it, packages it and labels it
Amneal Pharmaceuticals 0115-0511 , 0115-0522 , 0115-0533 Fluphenazine Packages it
Upsher-Smith Laboratories, Inc. 24979-136 , 24979-137 , 24979-138 +1Galantamine Packages 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 +3Megestrol Labels it
Upsher-Smith Laboratories, Inc. 24979-041 Monomethyl Packages it
Upsher-Smith Laboratories, Inc. 24979-127 , 24979-128 Nifedipine Makes it and packages it
Upsher-Smith Laboratories, Inc. 24979-009 , 24979-010 , 24979-011 Potassium Cation Makes it, tests it, packages it and labels it
Upsher-Smith Laboratories, Inc. 0245-0835 , 0245-0836 , 24979-229 +3Sevelamer Makes it, tests it and packages it
TWi Pharmaceuticals, Inc. , Westminster Pharmaceuticals, LLC 24979-186 , 69367-423 Terbutaline Packages it
Upsher-Smith Laboratories, Inc. 24979-132 , 24979-133 Topiramate Packages it
Upsher-Smith Laboratories, Inc. 24979-210 , 24979-211
FDA inspection history
Ended Result Program Problems noted
Jul 21, 2025 Problems found, fixed voluntarily Drug Quality Assurance — May 24, 2019 No problems found Drug Quality Assurance — Feb 17, 2017 No problems found Drug Quality Assurance — Apr 15, 2016 Problems found, fixed voluntarily Drug Quality Assurance 2 Jul 26, 2014 Problems found, fixed voluntarily Drug Quality Assurance — Jul 26, 2012 No problems found Drug Quality Assurance — Jun 18, 2009 Problems found, fixed voluntarily Drug Quality Assurance —
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Apr 15, 2016 inspection
Control procedures to monitor and validate performance 21 CFR 211.110(a) Written program not followed 21 CFR 211.166(a) Registered with FDA for: analysis; label; manufacture; pack.
