# FDA 483 - Drew J. Winston, MD - February 22, 2021

Source: https://www.keypedia.com/records/483/drew-j-winston-md/c139e782-bbbd-4c5a-8376-d09cb3f4a84d

> FDA 483 for Drew J. Winston, MD on February 22, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Drew J. Winston, MD
- Inspection Date: 2021-02-22
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Drew J. Winston, M.D., Clinical Investigator in Los Angeles, CA, from February 4-22, 2021, revealed a significant failure to report adverse effects to the sponsor. The investigator did not record numerous adverse events from subject source documents into the electronic case report forms (eCRFs) for two investigational drug studies.

## Related Officers

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

Company: https://www.keypedia.com/companies/drew-j-winston-md/e5bcc2fa-8dfb-43c2-90f6-2504862749dc

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