# FDA EIR - David J. Johnson, M.D. - July 13, 2018

Source: https://www.keypedia.com/records/eir/david-j-johnson-md/ce18d36d-f4ba-43cd-b056-4e70d909844c

> FDA EIR for David J. Johnson, M.D. on July 13, 2018. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: EIR
- Company Name: David J. Johnson, M.D.
- Inspection Date: 2018-07-13
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of Clinical Investigator David J. Johnson, M.D., conducted at Research Integrity, LLC. in Owensboro, KY, from July 9-13, 2018, focused on clinical research practices for a pre-market New Drug Application. Operating under Compliance Program 7348.811 and regulatory frameworks like 21 CFR 312.60 and 21 CFR 312.66, the inspection revealed significant violations. The primary issues included two study subjects receiving accidental overdoses of the investigational medicinal product, resulting in loss of consciousness, and a failure to adhere to protocol for processing pharmacokinetic samples, with no corresponding documentation. Crucially, these serious unanticipated problems were not promptly reported to the Institutional Review Board until just days before the inspection, months after the study's closure. Additional concerns involved incomplete documentation of study-related activities, such as equipment maintenance, and the creation of a backdated protocol deviation log. Dr. Johnson acknowledged the findings and committed to providing a written response, with the FDA emphasizing potential regulatory consequences up to investigator disqualification if comprehensive corrective actions are not implemented.

## Related Documents

- [EIR - 2018-07-13](https://www.keypedia.com/records/eir/david-j-johnson-md/0ab0582c-2567-4a96-93fc-bff262e26d8f)

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/kathryn-l-suttling/2d4695ca-5ec3-4658-8f46-101cec4ca41d)
- [Bioresearch Monitoring Foreign Inspection Cadre Member](https://www.keypedia.com/people/richard-w-berning/4637e321-8803-4fcf-911f-bbc810c3487d)
- [company_representative](https://www.keypedia.com/people/timothy-d-hillard/980869ea-e658-443e-b57b-f604ab5cc95c)
- [company_representative](https://www.keypedia.com/people/kishor-vora/af82c768-1ae0-41c2-9419-418b28d5eb0d)
- [company_representative](https://www.keypedia.com/people/david-b-johnson/b97eb398-a303-4d09-8728-51933b8fe073)

Company: https://www.keypedia.com/companies/david-j-johnson-md/40d8523c-3f78-490b-91df-4bd91b6e1661

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