# FDA 483 - William E. Sanchez, M.D. - December 22, 2021

Source: https://www.globalkeysolutions.net/records/483/william-e-sanchez-md/9d488c76-58a3-4fd4-b2f6-b23cea688a86

> FDA 483 for William E. Sanchez, M.D. on December 22, 2021. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: William E. Sanchez, M.D.
- Inspection Date: 2021-12-22
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: William E. Sanchez, M.D., a clinical investigator in Miami Lakes, FL, was inspected from December 7-22, 2021. The inspection revealed significant deviations from the investigational plan, including incorrect investigational product dose titration and administration, and providing investigational product before verifying subject inclusion criteria. Additionally, the firm failed to promptly report a serious adverse event to the study sponsor.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/emily-a-green/99d6d052-ed5c-4d09-9fad-f0d2b740725f)
- [Richard A. Lyght](https://www.globalkeysolutions.net/people/richard-a-lyght/8d60b5c0-4acd-4abc-979a-fb4b3e82964d)

Company: https://www.globalkeysolutions.net/companies/william-e-sanchez-md/3be414d2-8c45-4e7d-b8f3-a48c426f1a0f

Office: https://www.globalkeysolutions.net/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6