# FDA 483 - Steven D. Folkerth, M.D. - January 13, 2023

Source: https://www.keypedia.com/records/483/steven-d-folkerth-md/277d1abd-4b43-4ebc-ade5-0454726ff491

> FDA 483 for Steven D. Folkerth, M.D. on January 13, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Steven D. Folkerth, M.D.
- Inspection Date: 2023-01-13
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: The FDA inspected Clinical Research Center LLC in Dayton, OH, and identified significant deviations from investigational plans and inadequate record-keeping. Observations included the enrollment of ineligible subjects, incorrect administration of investigational product, failures in pharmacokinetic blood sampling, and unreported concomitant medications. Additionally, investigational drug disposition records were found to be inaccurate.

## Related Officers

- [investigator](https://www.keypedia.com/people/yvette-m-lacour-davis/8bae7c3f-2c46-4bf0-9e77-beaa25cdad91)

Company: https://www.keypedia.com/companies/steven-d-folkerth-md/3164acca-4fbc-4a78-b2c9-68a31e60fc72

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