FDA 483 - Zhejiang Yongtai Technology Co., Ltd.

An FDA inspection of Zhejiang Yongtai Technology Co., Ltd in Zhejiang, CN, revealed critical deficiencies in their laboratory operations. The firm failed to conduct thorough investigations into out-of-specification results, maintain complete batch production records, and ensure adequate environmental controls in laboratory facilities. These issues indicate a lack of robust quality control and data integrity practices impacting product quality and reliability.