# FDA 483 - Charles Redfern, MD - March 11, 2022

Source: https://www.keypedia.com/records/483/charles-redfern-md/0a943d29-e1e3-40a1-bcdb-5d94276a0394

> FDA 483 for Charles Redfern, MD on March 11, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Charles Redfern, MD
- Inspection Date: 2022-03-11
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Charles Redfern, MD in San Diego, CA, a clinical investigator, revealed a significant observation related to the conduct of a clinical study. The firm failed to follow the investigational plan, specifically regarding the administration and completion of PRO-CTCAE questionnaires and adherence to dose modification protocols for study subjects. This indicates a lack of adherence to study protocols during clinical trials.

## Related Officers

- [Christina D. Mello](https://www.keypedia.com/people/christina-d-mello/b523622e-d2dd-4ff6-9b2b-74b3134841de)

Company: https://www.keypedia.com/companies/charles-redfern-md/aaa97826-87aa-478e-be44-4a19e428c3d9

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