fda_483 · inspection_citation · high

Asahi Kasei Finechem Co., Ltd. -- FDA 483: 1 observation (2025-11-14)

Event date
2025-11-14 00:00:00Z
Observed
2026-07-12 22:31:32Z
Source ID
3002806404-2025-11-14-190692
Payload hash
987a96e8619f6f0a6e931d47

Summary

Observation 1: Methods used in testing must meet proper standards of accuracy and reliability as applied to the product tested. Specifically, Your firm has not performed method validation studies on i...

Informational only. Not legal, financial, or medical advice.