# FDA 483 - Richard Bernstein, MD, PhD - October 10, 2019

Source: https://www.globalkeysolutions.net/records/483/richard-bernstein-md-phd/63ca6cb8-2b4d-4bbd-8b2e-8f333c2d0fc5

> FDA 483 for Richard Bernstein, MD, PhD on October 10, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Richard Bernstein, MD, PhD
- Inspection Date: 2019-10-10
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: An FDA inspection of Richard Bernstein, MD, PhD, a clinical investigator in Chicago, IL, revealed significant deficiencies across two studies, RESPECT-ESUS and SOCRATES. Observations included widespread protocol deviations such as missing diagnostic evaluations, failure to re-image brains, incomplete screening procedures, and delayed reporting of adverse events. Additionally, the firm failed to obtain proper informed consent for sub-studies and did not implement revised consent forms, alongside maintaining inadequate and inaccurate case histories, including lost study records.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/shalonda-clifford/b6d67ba0-e40e-4347-9b58-a2bddc6983e3)
- [issuing_officer](https://www.globalkeysolutions.net/people/jennifer-c-adams/85608566-bd13-41d8-b86e-cc9111c7dfe5)

Company: https://www.globalkeysolutions.net/companies/richard-bernstein-md-phd/75512619-9480-4c3a-ab3c-aeca04cdb312

Office: https://www.globalkeysolutions.net/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669