# FDA 483 - Nicholas Onaca, M.D. - June 28, 2019

Source: https://www.keypedia.com/records/483/nicholas-onaca-md/f4995b7c-4b5e-4822-bf03-dc87ddd34899

> FDA 483 for Nicholas Onaca, M.D. on June 28, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Nicholas Onaca, M.D.
- Inspection Date: 2019-06-28
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: An FDA inspection of Nicholas Onaca, M.D., a clinical investigator in Dallas, TX, revealed that an investigation was not conducted in accordance with the investigational plan. Specifically, multiple subjects were consented, screened, and randomized into a study despite not meeting the established inclusion/exclusion criteria. This indicates significant deviations from the study protocol during subject enrollment.

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Company: https://www.keypedia.com/companies/nicholas-onaca-md/42166099-576c-426a-bed6-350102991b93

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