# FDA 483 - Zhejiang Dayang Biotech Group Co. Ltd. - November 20, 2025

Source: https://www.keypedia.com/records/483/zhejiang-dayang-biotech-group-co-ltd/f2991aa4-6212-4636-af3c-477772c52f3e

> FDA 483 for Zhejiang Dayang Biotech Group Co. Ltd. on November 20, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Zhejiang Dayang Biotech Group Co. Ltd.
- Inspection Date: 2025-11-20
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: An FDA inspection of Zhejiang Dayang Biotech Group Co. Ltd. revealed critical deficiencies across multiple areas, including inadequate controls over computer systems and analytical balances, leading to potential data integrity issues. The firm also failed to consistently perform growth promotion testing for microbiological media and lacked proper temperature controls in its warehouse, resulting in documented temperature excursions. Furthermore, the company had not conducted necessary hold time studies for crude or intermediate materials, raising concerns about product quality and suitability.

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Company: https://www.keypedia.com/companies/zhejiang-dayang-biotech-group-co-ltd/a7cc8d23-9dff-4f60-a397-4f029e6920a5

Office: https://www.keypedia.com/offices/office-of-partnerships/83acc701-fc5a-4876-bb34-7499e31541d3