# FDA 483 - Joshua M. Smith, M.D., MBA - December 08, 2022

Source: https://www.globalkeysolutions.net/records/483/joshua-m-smith-md-mba/7e3c8a90-04da-4146-97e3-4856d501f5a2

> FDA 483 for Joshua M. Smith, M.D., MBA on December 08, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Joshua M. Smith, M.D., MBA
- Inspection Date: 2022-12-08
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: Joshua M. Smith, M.D., MBA, a clinical investigator in Idaho Falls, ID, was cited for two significant issues during an FDA inspection from December 6-8, 2022. The inspection revealed that the investigator failed to conduct a clinical investigation according to the protocol, specifically by incorrectly dosing subjects in a leuprolide acetate study. Additionally, the firm failed to maintain adequate and accurate case histories by not documenting concomitant medications in electronic case report forms.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/sherri-n-rohlf/41090ab1-83d1-4e95-92ea-0cfca5cecdb6)

Company: https://www.globalkeysolutions.net/companies/joshua-m-smith-md-mba/a14bbf13-602e-4325-95a4-603299807cb3

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-vi/6e5a2a08-f464-4979-a759-7b0383370822