# FDA 483 - Qingdao Kangyuan Pharmaceutical Co. Ltd. - August 16, 2024

Source: https://www.keypedia.com/records/483/qingdao-kangyuan-pharmaceutical-co-ltd/e31e5b56-2548-42d7-969e-161523797700

> FDA 483 for Qingdao Kangyuan Pharmaceutical Co. Ltd. on August 16, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Qingdao Kangyuan Pharmaceutical Co. Ltd.
- Inspection Date: 2024-08-16
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: Qingdao Kangyuan Pharmaceutical Co. Ltd., an API drug manufacturer in Jiaozhou City, China, was cited for significant deficiencies across its laboratory, production, and equipment systems. Observations included inadequate water system monitoring and microbial testing, insufficient detail and time limits in batch production records, and failure to validate analytical methods. Additionally, the firm's manufacturing equipment was not maintained in a good state of repair, posing contamination risks.

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## Related Officers

- [Alan A. Rivera](https://www.keypedia.com/people/alan-a-rivera/4bec02c3-c62e-4b3a-a6ab-02c3386549bf)
- [investigator](https://www.keypedia.com/people/chad-w-rice/b00f381a-744d-4e5e-90bf-07f60f494afc)

Company: https://www.keypedia.com/companies/qingdao-kangyuan-pharmaceutical-co-ltd/8d3cd5ff-f332-4315-b8ad-efc53734f628

Office: https://www.keypedia.com/offices/office-of-partnerships/83acc701-fc5a-4876-bb34-7499e31541d3