# FDA 483 - Christine H. Lee, M.D. - June 17, 2022

Source: https://www.globalkeysolutions.net/records/483/christine-h-lee-md/7fc44400-715b-4f26-9dcd-ab637fca10ab

> FDA 483 for Christine H. Lee, M.D. on June 17, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Christine H. Lee, M.D.
- Inspection Date: 2022-06-17
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: Christine H. Lee, M.D., a clinical investigator in Victoria, British Columbia, was cited for significant deviations in conducting two investigational new drug studies (2014-01 and 2017-01). The inspection revealed failures in following study protocols, including enrolling ineligible subjects, issues with informed consent, drug misadministration, and inadequate adverse event reporting. These findings indicate serious concerns regarding patient safety and data integrity in clinical trials.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/christine-h-lee-md/ff898326-9ab7-4806-9c36-ab29cb8d5176

Office: https://www.globalkeysolutions.net/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321