# FDA 483 - Kurt Barnhart, MD - December 15, 2017

Source: https://www.globalkeysolutions.net/records/483/kurt-barnhart-md/1095078f-4e5e-49b7-9f3c-96bfe8cf3dc4

> FDA 483 for Kurt Barnhart, MD on December 15, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kurt Barnhart, MD
- Inspection Date: 2017-12-15
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: An FDA inspection of Kurt Barnhart, MD, a clinical investigator in Philadelphia, revealed significant deficiencies in the conduct of clinical investigations. Observations included failures to adhere to the signed statement of investigator, such as continuing a subject on exclusionary medication and enrolling subjects without complete lab results. Additionally, the firm failed to meet general requirements for informed consent by not re-consenting subjects to an updated form that included new risk factors.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/james-p-mcevoy/3c374f77-2c97-4a74-ba01-969316d641ca)

Company: https://www.globalkeysolutions.net/companies/kurt-barnhart-md/d2e3c404-d4ee-4fe0-b17f-3f0dbca3271f

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