# FDA 483 - Jennifer L. Crombie, M.D. - November 17, 2023

Source: https://www.globalkeysolutions.net/records/483/jennifer-l-crombie-md/b55697e5-a713-4aae-9a20-51d7da44756b

> FDA 483 for Jennifer L. Crombie, M.D. on November 17, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Jennifer L. Crombie, M.D.
- Inspection Date: 2023-11-17
- Product Type: drugs
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: Jennifer L. Crombie, M.D. in Boston, MA was inspected by the FDA from November 13-17, 2023, as a clinical investigator. The inspection revealed a significant deficiency in obtaining legally effective informed consent from study subjects. Specifically, updated informed consent documents were not signed by eight out of ten reviewed subjects, despite IRB approval for the updates and re-consenting plans.

## Related Officers

- [Meredith L. Miller](https://www.globalkeysolutions.net/people/meredith-l-miller/c775003b-4e5b-48d8-bc51-1a3ebe813dba)
- [issuing_officer](https://www.globalkeysolutions.net/people/kent-a-conforti/8d3d3e82-cd97-420e-8840-df92d6eeba09)

Company: https://www.globalkeysolutions.net/companies/jennifer-l-crombie-md/c53d3990-0474-4676-88d5-c0948bb6f108

Office: https://www.globalkeysolutions.net/offices/fda-district-office-stoneham-massachusetts/1daceb4f-4057-46cf-af02-d4ccde44dcc7