# FDA 483 - Scott T. Guenthner M.D. - September 26, 2019

Source: https://www.keypedia.com/records/483/scott-t-guenthner-md/1fba3897-bf86-40f7-b547-c9298dff015a

> FDA 483 for Scott T. Guenthner M.D. on September 26, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Scott T. Guenthner M.D.
- Inspection Date: 2019-09-26
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: The FDA inspected Scott T. Guenthner, M.D., Principal Investigator in Plainfield, IN, and issued a Form 483 with two observations. The inspection revealed that the investigation was not conducted in accordance with the investigational plan, specifically regarding the timing of subject assessments. Additionally, the firm failed to maintain accurate case histories, with discrepancies found between source documents and the Subject Drug Accountability Log for investigational product administration.

## Related Officers

- [Saikat I. Bhuiyan](https://www.keypedia.com/people/saikat-i-bhuiyan/92e63a0f-0893-419c-b8ee-2e57bb8b6c31)
- [U.S. Food and Drug Administration](https://www.keypedia.com/people/myra-k-casey/a2fae714-2ba3-4c60-9f54-990fc7b169c9)

Company: https://www.keypedia.com/companies/scott-t-guenthner-md/1de16cc7-579b-4247-be3a-cb3e23d23a7a

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0