# FDA 483 - Louise Charest, M.D. - September 29, 2017

Source: https://www.globalkeysolutions.net/records/483/louise-charest-md/e10780aa-2f8f-45db-b5f4-65ec0cd061b7

> FDA 483 for Louise Charest, M.D. on September 29, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Louise Charest, M.D.
- Inspection Date: 2017-09-29
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: An FDA inspection of Clinique Medicale L'Actuel, a clinical investigator, revealed a significant deficiency in obtaining legally effective informed consent. A subject in a clinical trial was administered study drug and underwent related tests after signing an informed consent form for a different study protocol. This lapse resulted in the subject participating in the study without appropriate consent.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/sherri-jackson/7d89f277-b44d-4987-a6fe-79c3f1c84f18)

Company: https://www.globalkeysolutions.net/companies/louise-charest-md/20f262f7-3695-4321-b14b-a006d1713451

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0