# FDA 483 - Philip M. Bolton, M.D. - July 23, 2020

Source: https://www.keypedia.com/records/483/philip-m-bolton-md/eb4ba6ca-1eb7-4213-bc65-84f9ff54ce04

> FDA 483 for Philip M. Bolton, M.D. on July 23, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Philip M. Bolton, M.D.
- Inspection Date: 2020-07-23
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: Philip M. Bolton, M.D., a clinical investigator, was cited for significant deficiencies during a human clinical study involving an investigational new drug. The inspection revealed failures to adhere to the study protocol, specifically regarding subject exclusion criteria and the use of prohibited medications. Additionally, the firm failed to maintain adequate and accurate case histories for study subjects.

## Related Officers

- [investigator](https://www.keypedia.com/people/sherri-n-rohlf/41090ab1-83d1-4e95-92ea-0cfca5cecdb6)

Company: https://www.keypedia.com/companies/philip-m-bolton-md/1954fadf-d3c8-4db7-8a12-b6fd852ad5d7

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-vi/6e5a2a08-f464-4979-a759-7b0383370822