# FDA 483 - Bailey, Timothy S., MD - October 13, 2020

Source: https://www.keypedia.com/records/483/bailey-timothy-s-md/416f04a6-728b-44e6-8d9d-950cad9e1e2c

> FDA 483 for Bailey, Timothy S., MD on October 13, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bailey, Timothy S., MD
- Inspection Date: 2020-10-13
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Timothy S. Bailey, MD in Escondido, CA, from October 6-13, 2020, revealed a significant deficiency in clinical investigations involving children. The principal investigator failed to consistently obtain permission from both parents, as mandated by 21 CFR 50.53, and did not document reasons for non-feasibility on informed consent forms. This indicates a procedural oversight in protecting vulnerable subjects in clinical trials.

## Related Officers

- [investigator](https://www.keypedia.com/people/dustin-r-abaonza/0a9994bd-d6ab-47cc-8f1b-5bf4d10bd852)

Company: https://www.keypedia.com/companies/bailey-timothy-s-md/c1b1c886-4e44-4c1f-81e0-f725e0edb2ae

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