Drug factory · FDA FEI 3004664162

Takeda Pharmaceutical Company Limited

4720, Takeda, Mitsui, Hikari, Japan

Problems found, fixed voluntarily at FDA's last inspection, Nov 6, 2023.

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

9 drug inspections on record since 2010: 1 with no problems, 7 with problems fixed voluntarily, 1 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Dexlansoprazole	Makes the active ingredient and tests it	TWi Pharmaceuticals, Inc.	24979-703, 24979-704

FDA inspection history

Ended	Result	Program	Problems noted
Nov 6, 2023	Problems found, fixed voluntarily	Drug Quality Assurance	—
Jul 19, 2021	Problems found, fixed voluntarily	Drug Quality Assurance	—
Nov 26, 2019	Serious problems, FDA action	Drug Quality Assurance	7
Nov 7, 2017	No problems found	Drug Quality Assurance	—
Oct 30, 2015	Problems found, fixed voluntarily	Drug Quality Assurance	—
Sep 18, 2013	Problems found, fixed voluntarily	Drug Quality Assurance	—
Jul 20, 2012	Problems found, fixed voluntarily	Drug Quality Assurance	—
Sep 29, 2011	Problems found, fixed voluntarily	Drug Quality Assurance	—
Sep 24, 2010	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.

Nov 26, 2019 inspection

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, written 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.
Failing drug products not rejected 21 CFR 211.165(f)
Drug products failing to meet established specifications are not rejected.
Extent of discrepancy, failure investigations 21 CFR 211.192
Investigations of a failure of a batch or any of its components to meet any of its specifications did not extend to other batches of the same drug product.
Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not maintained at appropriate intervals to prevent malfunctions that would alter the safety, identity, strength, quality or purity of the drug product.
Written procedures fail to include 21 CFR 211.67(b)
Written procedures for cleaning and maintenance fail to include maintenance and cleaning schedules, description in sufficient detail of methods, equipment and materials used, description in sufficient detail of the methods of disassembling and reassembling equipment as necessary to assure proper cleaning and maintenance and instructions for protection of clean equipment from contamination prior to use.

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