# FDA 483 - Kenneth B. Strenge, MD - May 16, 2024

Source: https://www.keypedia.com/records/483/kenneth-b-strenge-md/8f482390-c2c6-4d56-85d8-a966f7515769

> FDA 483 for Kenneth B. Strenge, MD on May 16, 2024. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kenneth B. Strenge, MD
- Inspection Date: 2024-05-16
- Product Type: other
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of Kenneth B. Strenge, MD in Paducah, KY, a clinical investigator, revealed a significant deviation from an investigational plan. The firm failed to conduct a clinical study according to its protocol by enrolling two subjects who met exclusionary criteria for an investigational device study. This indicates a failure to adhere to established study guidelines and subject eligibility requirements.

## Related Officers

- [investigator](https://www.keypedia.com/people/kellie-r-riggs/556818c6-eb9a-48a5-9630-aba7a807ec07)

Company: https://www.keypedia.com/companies/kenneth-b-strenge-md/08eeeb00-d89f-42e7-b4a3-e291064a5b42

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