# FDA 483 - Jonathan E. Isaacs, M.D. - February 28, 2025

Source: https://www.keypedia.com/records/483/jonathan-e-isaacs-md/22ffc98d-d6ff-40f0-8d9c-23c1dd2b1d51

> FDA 483 for Jonathan E. Isaacs, M.D. on February 28, 2025. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Jonathan E. Isaacs, M.D.
- Inspection Date: 2025-02-28
- Product Type: other
- Office Name: Office of Regulatory Affairs
- Summary: Jonathan E. Isaacs, M.D., a clinical investigator in Richmond, VA, was cited with two observations during an FDA inspection. The firm failed to provide complete temperature logs for an investigational product throughout a clinical trial, hindering record verification. Additionally, a serious adverse event was not reported promptly to the sponsor, exceeding the protocol-specified timeframe.

## Related Documents

- [483 - 2025-02-28](https://www.keypedia.com/records/483/jonathan-e-isaacs-md/d1f39811-2a1e-4891-9597-1f6bdf253f8b)

## Related Officers

- [Lucilla Facchin](https://www.keypedia.com/people/lucilla-facchin/e5c5c863-b2f4-44a8-8093-d1cb4f71949b)

Company: https://www.keypedia.com/companies/jonathan-e-isaacs-md/f06372ab-9d9e-45f5-a82c-7692ce07dd95

Office: https://www.keypedia.com/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64