Drug factory · FDA FEI 3004967045

Eisai Co., Ltd.

1, Kawashimatakehaya-Machi, Kakamigahara, Gifu, Japan

Problems found, fixed voluntarily at FDA's last inspection, Jun 5, 2026.

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

6 drug inspections on record since 2009: 3 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Ended	Result	Program	Problems noted
Jun 5, 2026	Problems found, fixed voluntarily	Drug Quality Assurance	—
Oct 27, 2023	Problems found, fixed voluntarily	Drug Quality Assurance	2
Dec 21, 2018	Problems found, fixed voluntarily	Drug Quality Assurance	7
Feb 19, 2016	No problems found	Drug Quality Assurance	—
Apr 26, 2012	No problems found	Drug Quality Assurance	—
Sep 11, 2009	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.

Storage under appropriate conditions 21 CFR 211.142(b)
Drug products are not stored under appropriate conditions of humidity so that their identity, strength, quality, and purity are not affected.
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.

Establishment of time limitations 21 CFR 211.111
Time limits are not established when appropriate for the completion of each production phase to assure the quality of the drug product.
Following/documenting laboratory controls 21 CFR 211.160(a)
Established laboratory control mechanisms are not followed.
Records not made readily available to FDA 21 CFR 211.180(c)
Records associated with drug product components and within the retention period for such records, were not made readily available for authorized inspection.
Training , Education , Experience overall 21 CFR 211.25(a)
Employees engaged in the manufacture and processing of a drug product lack the training required to perform their assigned functions.
Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not maintained at appropriate intervals to prevent contamination 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 instructions for removal or obliteration of previous batch identification.
Calibration/Inspection/Checking not done 21 CFR 211.68(a)
Routine inspection of equipment is not performed according to a written program designed to assure proper performance.

Registered with FDA for: analysis; manufacture.