# FDA 483 - Elizabeth I. Buchbinder, M.D. - October 03, 2022

Source: https://www.keypedia.com/records/483/elizabeth-i-buchbinder-md/c83a3a23-0462-4f50-8faf-96f5ba87bb5f

> FDA 483 for Elizabeth I. Buchbinder, M.D. on October 03, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Elizabeth I. Buchbinder, M.D.
- Inspection Date: 2022-10-03
- Product Type: drugs
- Office Name: Division of Northeast Imports 
- Summary: An FDA inspection of Dana Farber Cancer Institute in Boston, MA, revealed that a clinical investigation was not conducted in accordance with its investigational plan. Specifically, the firm failed to obtain required brain MRIs and CT scans for multiple subjects within the specified timeframes, with many scans being either missing or significantly delayed. This indicates a serious deviation from the study protocol.

## Related Officers

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

Company: https://www.keypedia.com/companies/elizabeth-i-buchbinder-md/d6b63ca6-7943-43e0-a744-8a88b5c06f6f

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