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

Source: https://www.globalkeysolutions.net/records/483/lead-chemical-co-ltd/da59f723-11b2-402a-ba5d-7a091d2066e4

> FDA 483 for Lead Chemical Co., Ltd. on July 24, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lead Chemical Co., Ltd.
- Inspection Date: 2025-07-24
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: 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.

## Related Officers

- [ Drug Investigator](https://www.globalkeysolutions.net/people/tekalign-wondimu/3b80e5c8-4062-4e1d-8ddd-b1afa2616dec)

Company: https://www.globalkeysolutions.net/companies/lead-chemical-co-ltd/b8997674-3f8e-4cd9-8f7d-1c677f4ea0f0

Office: https://www.globalkeysolutions.net/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8