Lead Chemical Co., Ltd.July 24, 2025

FDA 483 - Lead Chemical Co., Ltd. - July 24, 2025

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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.

Company: Lead Chemical Co., Ltd.
Inspection Date: July 24, 2025
Product Type: Drugs
Office: Office of Inspections and Investigations
Person: Tekalign Wondimu ( Drug Investigator)

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ID · da59f723-11b2-402a-ba5d-7a091d2066e4