# FDA 483 - Lee G. Rosen, MD, Principal Investigator - February 08, 2017

Source: https://www.keypedia.com/records/483/lee-g-rosen-md-principal-investigator/54405c35-ff23-4aa2-8361-2fd325086e00

> FDA 483 for Lee G. Rosen, MD, Principal Investigator on February 08, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lee G. Rosen, MD, Principal Investigator
- Inspection Date: 2017-02-08
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Lee G. Rosen, MD, Principal Investigator, identified a significant deviation in the conduct of a clinical investigation. The firm failed to ensure that only authorized and trained personnel prepared investigational product for subjects, contrary to the signed statement of investigator and delegation of duties log. This lapse raises concerns about adherence to study protocol and patient safety.

## Related Officers

- [investigator](https://www.keypedia.com/people/tawny-l-colling/4ce51467-468c-4271-a98d-4b13c15c0812)

Company: https://www.keypedia.com/companies/lee-g-rosen-md-principal-investigator/ba91e7ef-94b1-4c1d-b588-7bf4bfe46d32

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6