# FDA 483 - Charles J. Coté, MD - April 30, 2008

Source: https://www.globalkeysolutions.net/records/483/charles-j-cote-md/7ac15432-5b3e-413b-ba76-27c0ddb65967

> FDA 483 for Charles J. Coté, MD on April 30, 2008. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Charles J. Coté, MD
- Inspection Date: 2008-04-30
- Product Type: drugs
- Office Name: Division of Northeast Imports 
- Summary: This FDA Form 483 was issued to Massachusetts General Hospital in Boston, citing significant deficiencies in clinical trial conduct. The inspection revealed multiple issues related to inadequate and inaccurate case histories, improper informed consent documentation, and lack of investigator supervision during drug administration. These findings indicate serious concerns regarding data integrity and patient protection in clinical investigations.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/michelle-m-noe/8e925eca-5177-4ada-a6a9-47191cc42367)
- [investigator](https://www.globalkeysolutions.net/people/m-patricia-murphy/e955e45d-f8e3-46d3-a712-50dd075ca43c)

Company: https://www.globalkeysolutions.net/companies/charles-j-cote-md/61a37b34-2fd0-4c12-838f-90d809276348

Office: https://www.globalkeysolutions.net/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94