FDA 483 - Zhuhai United Laboratories Co. Ltd. - August 03, 2023

Zhuhai United Laboratories, Co., Ltd. in Zhuhai, China, an API Intermediate Manufacturer, was inspected by the FDA. The inspection revealed significant deficiencies across quality control, laboratory practices, production records, and equipment maintenance. Key issues include inconsistent specifications with the Drug Master File, inadequate investigation of unexpected chromatographic occurrences, poor control of recovered solvents, incomplete laboratory and batch production records, deficient cleaning procedures, and unsuitable analytical testing methods.