# Kenneth S. Sharlin, MD – FDA 483, May 1, 2026

Source: https://www.keypedia.com/records/483/kenneth-s-sharlin-md/b2d143d0-9d76-4978-9cda-ee731dad3fec

> FDA 483 for Kenneth S. Sharlin, MD on May 01, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kenneth S. Sharlin, MD
- Inspection Date: 2026-05-01
- Product Type: drugs
- Office Name: Kansas City District Office
- Summary: An FDA inspection of Sharlin Health and Neurology in Ozark, MO, revealed significant deficiencies in the conduct of clinical investigations. Observations included failures to adhere to investigational plans, such as issues with participant eligibility, late reporting of serious adverse events, and inadequate investigator staffing. Additionally, the firm failed to maintain adequate case histories, lacked proper documentation for key study procedures, and did not notify the IRB of a screening hold.

## Related Documents

- [EIR - 2026-05-01](https://www.keypedia.com/records/eir/kenneth-s-sharlin-md/7d3f9a2e-5c1b-4e8a-9f06-2b9186e5a3c1) — date: May 1, 2026

## Related Officers

- [Melissa S. Mcguinness](https://www.keypedia.com/people/melissa-s-mcguinness/5a7054ba-be7b-488a-a244-294b85c33d0b)

Company: https://www.keypedia.com/companies/kenneth-s-sharlin-md/1f554b7f-a9f2-4224-8cf9-7c48193d91da

Office: https://www.keypedia.com/offices/kansas-city-district-office/cd397ab1-df4e-46f1-ab1c-0f6db9abcf79