# FDA 483 - James Whitlock, M.D. - April 06, 2023

Source: https://www.globalkeysolutions.net/records/483/james-whitlock-md/73c2a6cc-bd7a-49e4-bdc5-d29edcb50920

> FDA 483 for James Whitlock, M.D. on April 06, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: James Whitlock, M.D.
- Inspection Date: 2023-04-06
- Product Type: drugs
- Office Name: Center for Veterinary Medicine
- Summary: An FDA inspection of James Whitlock, M.D., a clinical investigator in Toronto, revealed failures to conduct investigations in accordance with the investigational plan. Specifically, the firm was cited for under-reporting and late reporting of serious adverse events for subjects enrolled in a sponsored clinical protocol. These issues included misclassifying a grade 3 pancreatitis as grade 2 and submitting an expedited adverse event report beyond the protocol's allotted timeframe.

## Related Officers

- [Stuart W. Russell](https://www.globalkeysolutions.net/people/stuart-w-russell/59719ee0-e7b3-4e10-8d87-7c79eb2c2192)

Company: https://www.globalkeysolutions.net/companies/james-whitlock-md/da91d943-3f13-4f8d-9cbf-f36bf27c4f67

Office: https://www.globalkeysolutions.net/offices/center-for-veterinary-medicine/7e30a309-56e4-4e7a-8b8b-e07674bb07b4