# FDA 483 - Alan E. Kimura, M.D. - October 04, 2019

Source: https://www.keypedia.com/records/483/alan-e-kimura-md/f534b7e1-8747-45cc-b393-dab21a3202f3

> FDA 483 for Alan E. Kimura, M.D. on October 04, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Alan E. Kimura, M.D.
- Inspection Date: 2019-10-04
- Product Type: drugs
- Office Name: Denver District Office
- Summary: Alan E. Kimura, M.D. in Golden, CO, a clinical investigator, received an FDA Form 483 with two observations. The inspection revealed that investigational product was administered by unqualified staff, contrary to the study protocol. Additionally, the firm failed to maintain adequate case histories, as original source documents for investigational product dispensing were missing for multiple subjects.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/ruth-a-williams/f6dd5e30-fe9a-4b18-9703-dc471a55f24f)

Company: https://www.keypedia.com/companies/alan-e-kimura-md/492c092a-2adc-49af-a60e-82bbff0fb3e9

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