Zhuhai Rundu Pharmaceutical Co Ltd

FDA 483 - Zhuhai Rundu Pharmaceutical Co Ltd

Record Details

An FDA inspection of Zhuhai Rundu Pharmaceutical Co., Ltd. in Zhuhai, China, revealed two significant issues. The firm failed to conduct complete investigations into product complaints, specifically regarding API contamination. Additionally, the inspection found a lack of established schedules and procedures for the maintenance of critical equipment, leading to visible damage.

Company: Zhuhai Rundu Pharmaceutical Co Ltd
Product Type: Drugs
Office: Office of Biological Products Operations - Division I
Person: Jeffrey P. Raimondi (Consumer Safety Officer)

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