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# Astellas Pharma Japan Facility Hit with FDA-483
- URL: https://www.fdaweb.com/astellas-pharma-japan-facility-hit-with-fda-483/
- Published: 2024-11-18T12:00:00.000Z
- Updated: 2026-09-14T14:47:15.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158204

A 10/2023 FDA inspection of Astellas Pharma’s Shizuoka, Japan manufacturing facility resulted in a just-posted one-item [Form FDA-483](https://www.fda.gov/media/183579/download?ref=fdaweb.com). The agency investigators cited the facility’s complaint processing because its records were deficient. Specifically, the form said that a review of market complaints “revealed a lack of scientifically sound justification for the root cause.”