# FDA 483 - Peter Michael, M.D. - June 11, 2024

Source: https://www.globalkeysolutions.net/records/483/peter-michael-md/aa582689-d6ff-4447-a343-19b13bbf4164

> FDA 483 for Peter Michael, M.D. on June 11, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Peter Michael, M.D.
- Inspection Date: 2024-06-11
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: The FDA inspected G+C Research Group in Hialeah, FL, a clinical investigator, and found significant deficiencies. Observations included the overdosing of subjects with investigational product and a failure to conduct investigations according to the approved plan. Additionally, the firm failed to maintain adequate case histories, with unassessed laboratory reports and missing source documents for multiple subjects.

## Related Officers

- [Angelica M. Chica](https://www.globalkeysolutions.net/people/angelica-m-chica/117a5aa3-e5ed-46f2-bf32-885591c34848)

Company: https://www.globalkeysolutions.net/companies/peter-michael-md/6cd6ee9c-6631-400b-8c2d-fd4e9e888e73

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