483
Fujimoto Chemicals Co., Ltd.Fujimoto Chemicals Co., Ltd. – FDA 483, May 12, 2023
Record Details
Fujimoto Chemicals Co., Ltd. (Senboku Plant), an Active Pharmaceutical Ingredient (API) manufacturer in Izumiotsu, Osaka, was cited for deficiencies in establishing the reliability of component suppliers. The inspection revealed issues with verifying certificates of analyses for raw ingredients and a lack of current supplier audits for critical suppliers, with unverified corrective actions for major findings.
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ID · bf42527f-9a0d-4d4f-bcb5-8b5029d54f96
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