# FDA 483 - Kord Strebel, MD - August 25, 2021

Source: https://www.keypedia.com/records/483/kord-strebel-md/eea7a099-32ba-4381-90c9-31adb26fc575

> FDA 483 for Kord Strebel, MD on August 25, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kord Strebel, MD
- Inspection Date: 2021-08-25
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: An FDA inspection of Kord Strebel, MD in Las Vegas, NV, revealed significant deviations from a clinical study protocol for a Phase 3 trial. The firm failed to conduct investigations in accordance with the signed statement of investigator, citing issues with vital sign measurements, physical examinations, subject follow-up, and investigational product storage temperature records. These findings indicate a lack of adherence to established study protocols and good clinical practice.

## Related Documents

- [EIR - 2021-08-25](https://www.keypedia.com/records/eir/kord-strebel-md/c26fa7b3-6723-4824-a601-bd5b9e25c11c)

## Related Officers

- [investigator](https://www.keypedia.com/people/rebecca-t-davis/a821f7ef-0c73-4be1-9a9b-3fc2c07f88c1)

Company: https://www.keypedia.com/companies/kord-strebel-md/e0dc153e-955d-4cb6-a3ef-e01dbb6aebe9

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b