# FDA 483 - Zhuhai Rundu Pharmaceutical Co Ltd - February 17, 2025

Source: https://www.keypedia.com/records/483/zhuhai-rundu-pharmaceutical-co-ltd/cfca7b61-da42-402a-9ae4-568ad5f57d19

> FDA 483 for Zhuhai Rundu Pharmaceutical Co Ltd on February 17, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Zhuhai Rundu Pharmaceutical Co Ltd
- Inspection Date: 2025-02-17
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Zhuhai Rundu Pharmaceutical Co., Ltd., an API manufacturer in Zhuhai, China, was cited for significant quality control deficiencies. Observations included inadequate cleaning and maintenance of equipment, poor record-keeping practices, insufficient investigation of out-of-specification results, and a failure to conduct microbiological testing for distributed APIs. These issues indicate a lack of robust quality systems and potential risks to product quality.

## Related Documents

- [483 - Unknown Date](https://www.keypedia.com/records/483/zhuhai-rundu-pharmaceutical-co-ltd/a144946c-f584-42cd-9d1d-f97fe55b928e)

## Related Officers

- [Dipesh K. Shah](https://www.keypedia.com/people/dipesh-k-shah/d4df4040-13d1-477b-8c21-4c8e5b3fc5b9)

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

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8