Drug factory · FDA FEI 3010872322

Taiho Pharmaceutical Co., Ltd.

1-1, Iuchi, Takabo, Kitajima-cho, Itano-gun, Japan

Problems found, fixed voluntarily at FDA's last inspection, Jan 26, 2024.

Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.

2 drug inspections on record since 2015: 1 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Tipiracil and Trifluridine	Makes it and tests it	Taiho Pharmaceutical Co., Ltd.	64842-1020, 64842-1025

Ended	Result	Program	Problems noted
Jan 26, 2024	Problems found, fixed voluntarily	Drug Quality Assurance	2
May 22, 2015	No problems found	Drug Quality Assurance	—

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

Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans designed to assure that components and drug products conform to appropriate standards of identity, strength, quality and purity.
Calibration/Inspection/Checking not done 21 CFR 211.68(a)
Routine inspection and checking of automatic and mechanical equipment is not performed according to a written program designed to assure proper performance.

Registered with FDA for: analysis; manufacture.