# FDA 483 - Qingdao Kangyuan Pharmaceutical Co. Ltd. - April 18, 2026

Source: https://www.keypedia.com/records/483/qingdao-kangyuan-pharmaceutical-co-ltd/7e405f58-7a2a-4be2-b8fc-b0300d51e054

> FDA 483 for Qingdao Kangyuan Pharmaceutical Co. Ltd. on April 18, 2026. 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: 2026-04-18
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: An FDA inspection of Qingdao Kangyuan Pharmaceutical Co., Ltd. revealed significant deficiencies, many of which were repeat observations from a previous inspection. The firm failed to adequately characterize impurity profiles, qualify equipment, and maintain proper control over its HVAC and water systems. Additionally, issues were noted with scale calibration, equipment placement, and adherence to written procedures, indicating a lack of robust quality control in API manufacturing.

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## Related Officers

- [Investigator](https://www.keypedia.com/people/debra-i-love/96ceb077-2cad-4586-bdd0-b79ceee404ad)
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Company: https://www.keypedia.com/companies/qingdao-kangyuan-pharmaceutical-co-ltd/8d3cd5ff-f332-4315-b8ad-efc53734f628

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4