# FDA 483 - Bruce G. Redman, D.O. - January 11, 2019

Source: https://www.globalkeysolutions.net/records/483/bruce-g-redman-do/b63ca668-1175-4e57-8142-f3275d7461b3

> FDA 483 for Bruce G. Redman, D.O. on January 11, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bruce G. Redman, D.O.
- Inspection Date: 2019-01-11
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: Bruce G. Redman, D.O., a clinical investigator in Ann Arbor, MI, was cited for failing to conduct an investigation in accordance with the signed statement of investigator and investigational plan. Specifically, a study subject was provided with an incorrect medication for six weeks, resulting in significant adverse health effects including increased TSH levels, headaches, and an elevated oncology score. This indicates a serious deviation from study protocol and potential patient safety concerns.

## Related Officers

- [Andrace Deyampert](https://www.globalkeysolutions.net/people/andrace-deyampert/cdb4f833-488b-42b9-abab-4216435bce4c)

Company: https://www.globalkeysolutions.net/companies/bruce-g-redman-do/a82d8130-8214-457e-b221-44760923c444

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0