# FDA 483 - Andrew R. Gould, M.D. - August 08, 2019

Source: https://www.globalkeysolutions.net/records/483/andrew-r-gould-md/d478d64f-16be-4e6a-bce5-87dd8b5bc41b

> FDA 483 for Andrew R. Gould, M.D. on August 08, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Andrew R. Gould, M.D.
- Inspection Date: 2019-08-08
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of Andrew R. Gould, M.D., Clinical Investigator in Louisville, KY, revealed a significant lapse in subject protection. A vulnerable subject, identified as a ward of the state, was enrolled in an investigational study and underwent procedures without the necessary Institutional Review Board (IRB) approval. This indicates a serious failure to safeguard the rights and welfare of study participants.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/karen-m-cooper/4813e60d-c8da-4df2-bc48-ecfb06a55cf8)

Company: https://www.globalkeysolutions.net/companies/andrew-r-gould-md/73bc1e8e-a58f-4361-aa90-48620ea4f6c9

Office: https://www.globalkeysolutions.net/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22