# FDA 483 - Brian I Rini MD - January 25, 2019

Source: https://www.keypedia.com/records/483/brian-i-rini-md/fca0e5f0-1a22-44de-ad05-64cfa06db194

> FDA 483 for Brian I Rini MD on January 25, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Brian I Rini MD
- Inspection Date: 2019-01-25
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of Brian I Rini MD in Cleveland, OH, a clinical investigator site, revealed significant deficiencies in the reporting of adverse events and adherence to investigational plans. The firm failed to promptly report a serious adverse event to the sponsor and did not report numerous non-serious adverse events or concomitant medications as required by the study protocol. These findings indicate a serious lack of oversight in clinical trial conduct.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/kathryn-l-suttling/2d4695ca-5ec3-4658-8f46-101cec4ca41d)

Company: https://www.keypedia.com/companies/brian-i-rini-md/bccbbc05-0a90-4f1b-a444-6a57760b6418

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22