# FDA 483 - Arthur R. Cabrera, M.D. - May 16, 2023

Source: https://www.keypedia.com/records/483/arthur-r-cabrera-md/206d63d7-1979-4ce1-852d-3095e98ac4fc

> FDA 483 for Arthur R. Cabrera, M.D. on May 16, 2023. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Arthur R. Cabrera, M.D.
- Inspection Date: 2023-05-16
- Product Type: other
- Office Name: Denver District Office
- Summary: Arthur R. Cabrera, M.D. in Louisville, CO, a clinical investigator, was cited for significant deficiencies across three observations related to clinical trials involving investigational devices. Violations included failures in obtaining proper informed consent, inadequate disclosure to the IRB, and non-compliance with investigational device exemption requirements. Additionally, the firm failed to adequately monitor subject safety and adverse events, and investigational device labeling lacked required information.

## Related Officers

- [Theressa B. Smith](https://www.keypedia.com/people/theressa-b-smith/80f0c339-7eac-4c73-b9f6-ecb368738fe6)

Company: https://www.keypedia.com/companies/arthur-r-cabrera-md/852152ec-6d91-461c-aac5-ce322789f53e

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face