# FDA 483 - Zhuhai Rundu Pharmaceutical Co Ltd - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/zhuhai-rundu-pharmaceutical-co-ltd/a144946c-f584-42cd-9d1d-f97fe55b928e

> FDA 483 for Zhuhai Rundu Pharmaceutical Co Ltd on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Zhuhai Rundu Pharmaceutical Co Ltd
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: 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.

## Related Officers

- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/jeffrey-p-raimondi/7576ca4e-d9e8-4015-9ae6-9498e76058d3)

Company: https://www.globalkeysolutions.net/companies/zhuhai-rundu-pharmaceutical-co-ltd/41358c8c-249a-4cdb-bb26-259ff492823f

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1