# FDA 483 - Lewis, Karl D. MD - August 07, 2023

Source: https://www.globalkeysolutions.net/records/483/lewis-karl-d-md/89387a55-c2d7-494b-b9b6-8c60d7543b3a

> FDA 483 for Lewis, Karl D. MD on August 07, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lewis, Karl D. MD
- Inspection Date: 2023-08-07
- Product Type: drugs
- Office Name: Denver District Office
- Summary: An FDA inspection of Lewis, Karl D. MD, a clinical investigator in Aurora, CO, revealed significant deviations from the investigational plan and protocol requirements. Observations included failures to properly conduct investigations, maintain accurate case histories, and ensure proper informed consent procedures. These issues indicate serious non-compliance in the conduct of clinical trials.

## Related Officers

- [Theressa B. Smith](https://www.globalkeysolutions.net/people/theressa-b-smith/80f0c339-7eac-4c73-b9f6-ecb368738fe6)

Company: https://www.globalkeysolutions.net/companies/lewis-karl-d-md/939f4abf-526e-4cda-9b34-6d7de330da39

Office: https://www.globalkeysolutions.net/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face