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483
•Zhuhai Rundu Pharmaceutical Co Ltd

Zhuhai Rundu Pharmaceutical Co Ltd – FDA 483

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)
View Company Profile

ID · a144946c-f584-42cd-9d1d-f97fe55b928e

Other documents for Zhuhai Rundu Pharmaceutical Co Ltd
  • 483 - 2025-02-17February 17, 2025

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