# FDA 483 - Bernard H. Doft, M.D. - September 28, 2012

Source: https://www.keypedia.com/records/483/bernard-h-doft-md/31dbb0ee-436a-42d5-8fa1-88d758600a5d

> FDA 483 for Bernard H. Doft, M.D. on September 28, 2012. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bernard H. Doft, M.D.
- Inspection Date: 2012-09-28
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: An FDA inspection of Bernard H. Doft, M.D. in Pittsburgh, PA, a clinical investigator, revealed significant deficiencies in the conduct of clinical investigations. Observations included failures to adhere to the investigational plan, maintain accurate case histories, and properly obtain informed consent from human subjects. These findings indicate serious non-compliance with regulatory requirements for clinical trials.

## Related Officers

- [investigator](https://www.keypedia.com/people/erica-l-nicoll/30f831bd-3133-4fbc-977d-f9dda0dd6dab)

Company: https://www.keypedia.com/companies/bernard-h-doft-md/4cb98193-1847-4599-8deb-615b74be8e78

Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8