FDA 483 - Zhejiang Ruibang Laboratories Co., Ltd - September 11, 2023

Zhejiang Ruibang Laboritories Co., Ltd., an animal drug API manufacturer in Wenzhou, China, was cited for significant deficiencies across its operations. The inspection revealed issues with validation processes, inadequate laboratory methods and procedures, insufficient raw material identity testing, poor equipment maintenance, and inadequate pest control. These findings indicate a lack of robust quality systems and controls, posing potential risks to product quality and safety.