# FDA 483 - Bertrand P.  Cole, D.O. - May 16, 2025

Source: https://www.keypedia.com/records/483/bertrand-p-cole-do/15dafbe1-3b88-4bb0-bbee-1de12945179b

> FDA 483 for Bertrand P.  Cole, D.O. on May 16, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bertrand P.  Cole, D.O.
- Inspection Date: 2025-05-16
- Product Type: drugs
- Office Name: New England District Office
- Summary: An FDA inspection of Bertrand P. Cole, D.O., a clinical investigator in Portsmouth, NH, revealed a significant deviation in the conduct of a clinical study. All four subjects in the study were repeatedly overdosed with the Investigational Product, leading to adverse reactions and the interruption of their treatment. This issue stemmed from a failure to follow drug handling instructions and the protocol's titration regimen.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/kent-a-conforti/8d3d3e82-cd97-420e-8840-df92d6eeba09)

Company: https://www.keypedia.com/companies/bertrand-p-cole-do/d41a39f1-7e14-4cd7-95f8-471e2a081efa

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144