483
Lead Chemical Co., Ltd.FDA 483 - Lead Chemical Co., Ltd. - July 24, 2025
Record Details
Lead Chemical Co., Ltd. in Toyama, Japan, an OTC drug manufacturer, was cited by the FDA for a significant quality control deficiency. The firm failed to take representative samples and perform specific limit testing for contamination on incoming lots of components used in their OTC drug products. This indicates a potential risk to product quality and patient safety.
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ID · da59f723-11b2-402a-ba5d-7a091d2066e4