FDA 483 - Eisai Company Ltd. - October 27, 2023

From October 23-27, 2023, the FDA inspected Eisai Company Ltd., a manufacturer located in Kakamigahara, Gifu, Japan. The inspection, led by Investigators Bijoy Panicker and Ankur C Patel, resulted in two observations noted on Form FDA 483.

Observation 1 details deficiencies in the quality control unit's responsibilities and procedures. Specifically, the Quality Unit lacks control over the issuance of batch manufacturing records, as the production planning group can directly print these from the MAQS software system without QA oversight, contrary to SOP # MJ203-01-PM0021, Revision: 04. Additionally, QA does not verify warehouse personnel's review of warehouse temperature monitoring data, nor does it perform periodic spot checks of this data, as required by SOP # MJ301-01-DW0002, Revision: 14.

Observation 2 concerns the storage conditions of drug products. The firm stores capsules, specifically (b)(4) Capsules, Size (b)(4), Lot #(b)(4), used for manufacturing (b)(4) Capsules, in Warehouse 2. This warehouse lacks humidity control and predefined humidity specification limits. The capsule supplier recommends storage conditions of (b)(4)°C and (b)(4)% RH for these capsules, indicating that the current storage conditions may affect the identity, strength, quality, and purity