# FDA 483 - Jessica Kaffenberger, M.D. - March 13, 2020

Source: https://www.keypedia.com/records/483/jessica-kaffenberger-md/40834d99-aeee-4456-9f10-dd1c9bfcb609

> FDA 483 for Jessica Kaffenberger, M.D. on March 13, 2020. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Jessica Kaffenberger, M.D.
- Inspection Date: 2020-03-13
- Product Type: other
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of Jessica Kaffenberger, M.D. in Gahanna, OH, a clinical investigator, revealed a significant issue regarding informed consent for pediatric subjects. The investigator failed to consistently obtain permission from both parents for children enrolled in a clinical investigation, as required by regulations. This deficiency was noted for both initial and reconsented subjects, with no documentation provided to explain the absence of a second parental signature.

## Related Officers

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

Company: https://www.keypedia.com/companies/jessica-kaffenberger-md/39a0b196-5ffd-4456-b43e-baa2e2a99152

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