# FDA 483 - Harold S. Minkowitz, M.D. - April 30, 2018

Source: https://www.keypedia.com/records/483/harold-s-minkowitz-md/cf4b8017-062f-43fc-9c49-de507b5e782e

> FDA 483 for Harold S. Minkowitz, M.D. on April 30, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Harold S. Minkowitz, M.D.
- Inspection Date: 2018-04-30
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: An FDA inspection of Harold S. Minkowitz, M.D. in Houston, TX, revealed significant deficiencies in the conduct of a Phase III clinical investigation. The firm failed to ensure the investigation was conducted according to the investigational plan, with issues including undocumented sub-investigator training and numerous protocol violations. These violations involved subjects receiving disallowed antiemetic drug therapies.

## Related Officers

- [CSO](https://www.keypedia.com/people/andrea-a-branche/9ffe9b53-7963-49a6-be4e-25e644f1759f)

Company: https://www.keypedia.com/companies/harold-s-minkowitz-md/94693094-97fa-4c21-9c74-dbcaca994967

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9