# Lin Shen, M.D. – FDA 483, May 6, 2026

Source: https://www.keypedia.com/records/483/lin-shen-md/8700ce27-dccb-4200-9e7c-7ced56498a08

> FDA 483 for Lin Shen, M.D. on May 06, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lin Shen, M.D.
- Inspection Date: 2026-05-06
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Lin Shen, MD, a clinical investigator in Beijing, revealed significant deficiencies in conducting a clinical investigation. The firm failed to administer chemotherapy according to protocol specifications for multiple subjects in a clinical trial. Additionally, the inspection found issues with maintaining complete source documents, as notepads used for subject assessments were not included in subject data files.

## Related Documents

- [483 - 2023-11-17](https://www.keypedia.com/records/483/lin-shen-md/a99e9c42-053c-4486-a43a-1bb7b082e4d8) — date: November 17, 2023

## Related Officers

- [investigator](https://www.keypedia.com/people/courtney-n-long/32118415-bc77-4ac2-8f90-947e43cf10ff)

Company: https://www.keypedia.com/companies/lin-shen-md/38ec4e28-dc8d-443d-a07a-09d1c8a4fbf7

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8