# FDA 483 - Yangzhou H&R Plastic Daily Chemical Co., Ltd. - October 24, 2025

Source: https://www.keypedia.com/records/483/yangzhou-hr-plastic-daily-chemical-co-ltd/e7aa1498-f45a-43c8-ae5d-bbd9831321da

> FDA 483 for Yangzhou H&R Plastic Daily Chemical Co., Ltd. on October 24, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Yangzhou H&R Plastic Daily Chemical Co., Ltd.
- Inspection Date: 2025-10-24
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Yangzhou H&R Plastic Daily Chemical Co., Ltd. in Yangzhou, China, revealed significant deficiencies across its OTC drug manufacturing operations. The firm failed to implement adequate quality control unit procedures, process validation, raw material identity testing, labeling controls, laboratory controls, and equipment cleaning and maintenance. These issues indicate a systemic lack of adherence to current good manufacturing practices, posing risks to drug product quality and purity.

## Related Documents

- [483 - 2025-10-31](https://www.keypedia.com/records/483/yangzhou-hr-plastic-daily-chemical-co-ltd/15d30856-48db-4dd6-acd3-2cb829c3d544)
- [WARNING_LETTER - 2025-10-24](https://www.keypedia.com/records/warning_letter/yangzhou-hr-plastic-daily-chemical-co-ltd/3a41e913-dafa-4543-9ad9-50fbbd204236)

## Related Officers

- [Consumer Safety Officer , Investigator](https://www.keypedia.com/people/lisa-r-hilliard/611735cf-5c20-424c-801a-03888d8d1b0a)

Company: https://www.keypedia.com/companies/yangzhou-hr-plastic-daily-chemical-co-ltd/82d1d0d7-d678-4540-9d65-98fb1cf5dbcb

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