# FDA 483 - David S. Krakow, M.D. - November 21, 2025

Source: https://www.keypedia.com/records/483/david-s-krakow-md/b602cf6f-57ab-488e-bdaa-53842608bf24

> FDA 483 for David S. Krakow, M.D. on November 21, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: David S. Krakow, M.D.
- Inspection Date: 2025-11-21
- Product Type: drugs
- Office Name: New York District Office
- Summary: An FDA inspection conducted from November 13 to November 21, 2025, identified significant compliance issues at the facility of Clinical Investigator David S. Krakow. The inspection, documented in an FDA Form 483, highlighted critical deficiencies in the conduct of a clinical investigation and the informed consent process. A primary observation noted that the investigation was not carried out in accordance with the signed investigator statement and approved investigational plan. Specifically, one subject was enrolled and received the investigational product prior to obtaining the necessary Institutional Review Board (IRB) approval for the site's participation. Furthermore, the inspection revealed a failure to secure proper informed consent from human subjects as mandated by regulatory requirements. For one minor subject, there was no documentation of an IRB-approved assent form, and the signature page for the parental informed consent form was missing. An additional finding indicated that the written informed consent utilized in the study was not approved by the IRB, and lacked dates from subjects or their legally authorized representatives at the time of consent. This issue impacted two subjects who received the investigational product without duly signed, IRB-approved consent forms. These observations indicate non-compliance with regulations concerning human subject protection, particularly 21 CFR Part 50 regarding informed consent. The Clinical Investigator is required to address these findings and implement corrective actions to ensure future adherence to regulatory standards and ethical research practices.

## Related Officers

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

Company: https://www.keypedia.com/companies/david-s-krakow-md/3f8e6ca7-d909-44eb-b3f8-606a2783d7d1

Office: https://www.keypedia.com/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d