# FDA 483 - David M Francyk - October 20, 2017

Source: https://www.globalkeysolutions.net/records/483/david-m-francyk/623c16b6-56e1-40e6-80fb-ec0288df944c

> FDA 483 for David M Francyk on October 20, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: David M Francyk
- Inspection Date: 2017-10-20
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: An FDA inspection of David M. Francyk, DO, Clinical Investigator in Phoenix, AZ, revealed significant deficiencies in the conduct of clinical investigations. Observations included failure to follow the investigational plan and exclusion criteria, inadequate maintenance of case histories, and conducting study procedures prior to obtaining informed consent from subjects. These issues indicate a serious lack of adherence to regulatory requirements and protocol.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/sandra-saniga/a1a89397-a095-46de-9355-aa1cd88d729a)

Company: https://www.globalkeysolutions.net/companies/david-m-francyk/a34ee1b0-281e-4d24-8be4-1847d2a53eda

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b