# FDA 483 - Jon B. Cole, MD - April 26, 2019

Source: https://www.globalkeysolutions.net/records/483/jon-b-cole-md/62a13e95-a254-4444-bf55-3f21232420e2

> FDA 483 for Jon B. Cole, MD on April 26, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Jon B. Cole, MD
- Inspection Date: 2019-04-26
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: Dr. Jon B. Cole, a clinical investigator in Minneapolis, was cited for significant non-compliance during an FDA inspection of his clinical investigations. The inspection revealed failures to submit Investigational New Drug applications, obtain legally effective informed consent, and conduct investigations according to the approved plan. Additionally, issues included untimely reporting of serious adverse events, inadequate study monitoring, and insufficient investigational drug disposition records.

## Related Documents

- [WARNING_LETTER - 2019-04-26](https://www.globalkeysolutions.net/records/warning_letter/jon-b-cole-md/82673613-729f-40f9-b31f-5964d3f51fe6)
- [483 - 2019-04-23](https://www.globalkeysolutions.net/records/483/jon-b-cole-md/0002e68c-67b8-4ab8-9499-a948bccbeb82)
- [483 - 2019-04-26](https://www.globalkeysolutions.net/records/483/jon-b-cole-md/999ce8ad-edd6-4748-b8f4-ffa453ef3c54)

## Related Officers

- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/kellie-l-thommes/255a1b92-cd56-41f5-9622-82e8a629e153)

Company: https://www.globalkeysolutions.net/companies/jon-b-cole-md/27c48443-d298-4946-b980-7543615a8d30

Office: https://www.globalkeysolutions.net/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d