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

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.