# FDA 483 - David Gerber, M.D. - August 19, 2019

Source: https://www.globalkeysolutions.net/records/483/david-gerber-md/7301a502-d5f1-44b3-967b-311e23ce00b1

> FDA 483 for David Gerber, M.D. on August 19, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: David Gerber, M.D.
- Inspection Date: 2019-08-19
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: David Gerber, M.D., a clinical investigator in Dallas, TX, received a Form 483 for significant deficiencies observed during an FDA inspection. The firm failed to conduct an investigation in accordance with the signed statement of investigator and investigational plan, including issues with timely IRB reporting, screening assessments, and treatment protocols. Additionally, the inspection revealed a failure to promptly report serious adverse events (SAEs) to the sponsor and ensure timely investigator review.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/camille-d-brown/419869d2-1810-40ea-8e8a-687de7013f6a)

Company: https://www.globalkeysolutions.net/companies/david-gerber-md/1d94b600-3b17-419d-90c1-f4291ff6526f

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