AGC WAKASA CHEMICALS CO., LTD. – FDA 483, Aug 21, 2026
During an inspection, AGC Wakasa Chemicals Co., Ltd, an API and Intermediate Manufacturer in Obama, Fukui, Japan, was cited for significant quality control deficiencies. Observations included inadequate investigation and follow-up for out-of-specification and deviation test results, with instances of retesting lacking scientific justification. Additionally, the firm failed to requalify the HVAC system and perform temperature mapping for a critical clean room used for API filling since its construction in 2012.
ID · 96649359-b32b-4a7b-ac0c-93b7e1f38cc4
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