Drug factory · FDA FEI 3002840477

ScinoPharm Taiwan, Ltd.

No.1, Nan-Ke 8th Road, Shan-Hua, Tainan, Taiwan

Serious problems, FDA action at FDA's last inspection, Jun 23, 2026.

Official Action Indicated: inspectors found significant problems and FDA recommended regulatory action, such as a warning letter or import alert.

7 drug inspections on record since 2008: 4 with no problems, 2 with problems fixed voluntarily, 1 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Dantrolene	Makes the active ingredient	Eagle Pharmaceuticals, Inc.	42367-540
Delafloxacin	Makes the active ingredient, tests it and packages it	Melinta Therapeutics, LLC	70842-101, 70842-102
Eflornithine	Makes the active ingredient, tests it and packages it	Uswm, LLC	78670-150
Fondaparinux	Makes the active ingredient	Italfarmaco S.p.A, Zydus Pharmaceuticals (USA) Inc.	11797-154, 11797-155, 11797-156 +5
Glatiramer	Makes it, makes the active ingredient, tests it and packages it	Upsher-Smith Laboratories, Inc.	0832-6084, 0832-6085
Irinotecan	Makes the active ingredient	Ipsen Biopharmaceuticals, Inc.	15054-0043
Leuprolide	Makes the active ingredient	Accord BioPharma Inc., Foresee Pharmaceuticals Co., Ltd.	69448-023, 72851-042
Tamsulosin	Makes the active ingredient	Sanofi-Aventis U.S. LLC	0024-5837
Topotecan	Makes the active ingredient	Fresenius Kabi, LLC	63323-762

Ended	Result	Program	Problems noted
Jun 23, 2026	Serious problems, FDA action	Drug Quality Assurance	7
Oct 25, 2022	No problems found	Drug Quality Assurance	—
May 17, 2019	No problems found	Drug Quality Assurance	—
Feb 10, 2017	No problems found	Drug Quality Assurance	—
Mar 27, 2015	No problems found	Drug Quality Assurance	—
Mar 29, 2012	Problems found, fixed voluntarily	Drug Quality Assurance	—
Oct 23, 2008	Problems found, fixed voluntarily	Drug Quality Assurance	—

From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.

Procedures for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed.
Validation lacking for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic and sterilization process.
Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
Training , Education , Experience overall 21 CFR 211.25(a)
Employees engaged in the processing of a drug product lack the training required to perform their assigned functions.
Product flow through building is inadequate 21 CFR 211.42(b)
The flow of components, drug product containers, closures, in-process materials and drug products through the building is not designed to prevent contamination.
input/output verification 21 CFR 211.68(b)
Input to and output from the computer are not checked for accuracy.

Registered with FDA for: analysis; api manufacture; manufacture; pack; relabel; repack.