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# Eisai Facility FDA-483 Out
- URL: https://www.fdaweb.com/eisai-facility-fda-483-out/
- Published: 2024-09-24T12:00:00.000Z
- Updated: 2026-09-14T14:42:13.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157844

FDA has just released the form FDA-483 issued following a 10/23-10/27/2023 inspection at the Eisai drug manufacturing facility in Gifu, Japan. The two observations were:

- failure to maintain in writing and fully follow the responsibilities and procedures applicable to the quality control unit; and
- failure to store drug products under appropriate conditions of humidity so that their identity, strength, quality, and purity are not affected.