# FDA 483 - Sait Ashina, M.D. - April 08, 2025

Source: https://www.globalkeysolutions.net/records/483/sait-ashina-md/c760b8e9-10be-4f8a-b089-063f9d6fa818

> FDA 483 for Sait Ashina, M.D. on April 08, 2025. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Sait Ashina, M.D.
- Inspection Date: 2025-04-08
- Product Type: drugs
- Office Name: New England District Office
- Summary: Dr. Sait Ashina, M.D., a clinical investigator in Boston, MA, was cited for significant deviations from investigational plans and inadequate record-keeping during an FDA inspection. The inspection revealed failures to adhere to study protocols, including enrolling ineligible subjects and not completing required monitoring, as well as issues with maintaining complete and timely case histories. These findings indicate serious deficiencies in the conduct and documentation of clinical trials.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/kent-a-conforti/8d3d3e82-cd97-420e-8840-df92d6eeba09)

Company: https://www.globalkeysolutions.net/companies/sait-ashina-md/c6fa4542-ae8c-4438-948f-8b3667ab5408

Office: https://www.globalkeysolutions.net/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144