# FDA 483 - Yangzhou H&R Plastic Daily Chemical Co., Ltd. - October 31, 2025

Source: https://www.keypedia.com/records/483/yangzhou-hr-plastic-daily-chemical-co-ltd/15d30856-48db-4dd6-acd3-2cb829c3d544

> FDA 483 for Yangzhou H&R Plastic Daily Chemical Co., Ltd. on October 31, 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: 2025-10-31
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Changzhou Qianhong Bio-Pharma Co., Ltd., an API manufacturer in Changzhou, China, revealed a significant failure to establish and document specifications for raw materials, intermediates, and APIs. Specifically, the firm did not define or verify hold time limits for materials and intermediates, impacting the quality of API batches distributed to the U.S. market. This indicates a serious lapse in quality control and assurance.

## Related Documents

- [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-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1