# FDA 483 - Neil S. Sadick,  M.D. - October 09, 2024

Source: https://www.keypedia.com/records/483/neil-s-sadick-md/0ae2e728-52ba-4565-83aa-d8f2ebc8a66d

> FDA 483 for Neil S. Sadick,  M.D. on October 09, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Neil S. Sadick,  M.D.
- Inspection Date: 2024-10-09
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Neil S. Sadick, M.D. (Sadick Anesthetic Surgery & Dermatology) in New York, NY, revealed that an investigation was not conducted in accordance with the signed statement of investigator and investigational plan. The firm failed to re-consent subjects after protocol amendments that altered study design or increased potential risk, and did not ensure documented medical histories were available to verify inclusion and exclusion criteria for some participants. These findings indicate significant deviations from established clinical trial protocols and subject protection requirements.

## Related Documents

- [483 - 2024-10-09](https://www.keypedia.com/records/483/neil-s-sadick-md/8ddf6194-055b-4f4f-8173-3abd39c154c9)

## Related Officers

- [Kerun Hardeo](https://www.keypedia.com/people/kerun-hardeo/d6c75a34-ab9b-4541-883d-102c6ec8c131)

Company: https://www.keypedia.com/companies/neil-s-sadick-md/1e42ac6d-f0ef-40b2-92a1-b9dfbd5b8fd9

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961