# FDA 483 - Lin Shen - November 17, 2023

Source: https://www.globalkeysolutions.net/records/483/lin-shen/a99e9c42-053c-4486-a43a-1bb7b082e4d8

> FDA 483 for Lin Shen on November 17, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lin Shen
- Inspection Date: 2023-11-17
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Shen, Lin, MD, a clinical investigator in Beijing, China, revealed significant deviations from the investigational plan for a Phase 3 study on metastatic gastric or gastroesophageal junction adenocarcinoma. The firm failed to adhere to the study protocol by enrolling subjects who met exclusion criteria and by not discontinuing a subject experiencing a severe adverse event. These findings indicate a lack of adherence to the study's established procedures.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/koffi-a-amegadje/817a228e-0003-43d0-bf59-71aeba0fd1f5)

Company: https://www.globalkeysolutions.net/companies/lin-shen/38ec4e28-dc8d-443d-a07a-09d1c8a4fbf7

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