FDA 483 - Zhuhai United Laboratories Co. Ltd. - September 11, 2017

Zhuhai United Laboratories Co., Ltd., an API/Sterile Finished Drug Product Manufacturer in Zhuhai, China, was cited for significant deficiencies during an FDA inspection. The observations highlight severe data integrity issues, including the deletion and modification of raw electronic data, inadequate laboratory investigation procedures for out-of-specification results, and unscientific testing methods. Additionally, the firm failed to properly investigate deviations, maintain adequate controls over electronic systems, and ensure proper aseptic processing and visual inspection practices.