# Qingdao Kangyuan Pharmaceutical Co. Ltd. – FDA 483

Source: https://www.keypedia.com/records/483/qingdao-kangyuan-pharmaceutical-co-ltd/e3961d85-f4fd-4c24-bcc6-b2e3e62a5f78

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

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## Details

- Record Type: 483
- Company Name: Qingdao Kangyuan Pharmaceutical Co. Ltd.
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: An FDA inspection of Qingdao Kangyuan Pharmaceutical Co., Ltd in Qindao, China, revealed numerous deficiencies in their API production. Key issues included inadequate product testing against USP standards, lack of validated stability and impurity profiling methods, and poor control over manufacturing processes and equipment. The findings indicate significant gaps in the firm's quality management system and adherence to good manufacturing practices.

## Related Documents

- [483 - 2026-04-18](https://www.keypedia.com/records/483/qingdao-kangyuan-pharmaceutical-co-ltd/7e405f58-7a2a-4be2-b8fc-b0300d51e054) — date: April 18, 2026
- [483 - 2024-08-16](https://www.keypedia.com/records/483/qingdao-kangyuan-pharmaceutical-co-ltd/2e766891-76eb-4944-b8bb-4283c2e1adb8) — date: August 16, 2024

## Related Officers

- [Jose R. Hernandez](https://www.keypedia.com/people/jose-r-hernandez/7a28c3ee-b023-44cc-b179-b89798e2f72f)

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