# FDA 483 - Jiyu Wen - September 22, 2023

Source: https://www.keypedia.com/records/483/jiyu-wen/703aa997-7a67-465c-b724-c0d576a4aad5

> FDA 483 for Jiyu Wen on September 22, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Jiyu Wen
- Inspection Date: 2023-09-22
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Affiliated Hospital of Guangdong Medical University in Zhanjiang, China, revealed significant deviations from its investigational plan during a clinical study. Deficiencies included subjects being screened before obtaining informed consent, inadequate record-keeping for CT images and ECG reports, and improper management of investigational medical products. The findings indicate a failure to adhere to Good Clinical Practice.

## Related Officers

- [Janete F. Guardia](https://www.keypedia.com/people/janete-f-guardia/2405f83f-7ea9-4056-afbd-7d9c00a6e169)
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Company: https://www.keypedia.com/companies/jiyu-wen/294f67be-7e0f-4c36-91d6-20387e99675b

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd