FDA 483 - Zhejiang Regen Chemical Co., Ltd. - November 25, 2019

An FDA inspection of Zhejiang Regen Chemical Co., Ltd. in Taizhou, Zhejiang, revealed significant deficiencies in laboratory controls, data integrity, and quality systems. Observations included inadequate method validation, lack of system suitability testing, improper use of reference standards, and insufficient software security. Additionally, the firm failed to conduct stability testing, visually inspect reserve samples, and maintain detailed cleaning procedures.