483
Taiho Pharmaceutical Co., Ltd.Taiho Pharmaceutical Co., Ltd. – FDA 483, Jan 26, 2024
Record Details
An FDA inspection of Taiho Pharmaceutical Co., Ltd., a bulk drug manufacturer in Itano-Gun, Tokushima, Japan, revealed significant deficiencies in equipment maintenance and laboratory controls. Inspectors observed that corroded equipment was used for an extended period without proper investigation or justification, impacting tablet manufacturing. Additionally, the firm failed to perform adequate growth promotion testing for microbial media used in product testing.
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ID · 3ae477b2-2913-43d2-a8ab-92d073f60c3b
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