# FDA 483 - David R. Hensley, MD - August 02, 2019

Source: https://www.globalkeysolutions.net/records/483/david-r-hensley-md/9d2ec57b-7138-46da-96bb-7c2d32ae79fd

> FDA 483 for David R. Hensley, MD on August 02, 2019. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: David R. Hensley, MD
- Inspection Date: 2019-08-02
- Product Type: other
- Office Name: Dallas District Office
- Summary: The FDA inspected David R. Hensley, MD, a clinical investigator in Arlington, TX, and issued a Form 483 with two observations. The inspection revealed that the clinical investigation was not properly conducted or supervised by Dr. Hensley, with significant tasks delegated to the Director of Research. Additionally, the firm failed to maintain accurate case histories, evidenced by missing records and numerous discrepancies in signatures, initials, and dates on subject source documents and informed consent forms.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/michelle-j-hines/c8087e41-6b8a-4b9a-92ad-bba500ce6fee)

Company: https://www.globalkeysolutions.net/companies/david-r-hensley-md/7993a043-4f38-4152-9d15-d11e31ec31ad

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