# FDA 483 - Glenn Gandelman, M.D. - March 10, 2023

Source: https://www.keypedia.com/records/483/glenn-gandelman-md/b7b6cd83-4e9a-443f-824f-e21c19e51512

> FDA 483 for Glenn Gandelman, M.D. on March 10, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Glenn Gandelman, M.D.
- Inspection Date: 2023-03-10
- Product Type: drugs
- Office Name: Division of Northeast Imports 
- Summary: An FDA inspection of Greenwich Cardiology Associates, Llc in Greenwich, CT, revealed significant deficiencies in the informed consent process for a clinical study. The firm failed to obtain proper informed consent from human subjects prior to conducting study-related tests and used unapproved consent forms. These issues indicate a lack of adherence to regulatory requirements for human subject protection.

## Related Officers

- [Matthew C. Watson](https://www.keypedia.com/people/matthew-c-watson/a1594b84-f65a-42f9-a06d-a68a49eb4b28)

Company: https://www.keypedia.com/companies/glenn-gandelman-md/6517be7a-9082-4dc0-b6b2-bf2e5d785414

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