# FDA 483 - Josefa Binker, M.D. - July 25, 2019

Source: https://www.keypedia.com/records/483/josefa-binker-md/06dda451-5315-4ed9-8774-6f3fb4fce96e

> FDA 483 for Josefa Binker, M.D. on July 25, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Josefa Binker, M.D.
- Inspection Date: 2019-07-25
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Josefa Binker, M.D., a clinical investigator in Homestead, FL, revealed significant issues with adherence to investigational plans. The inspection found that subjects were enrolled in studies without meeting the specified inclusion and exclusion criteria, indicating a failure to properly conduct clinical investigations. This could compromise the integrity and reliability of the study data.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/kathryn-l-suttling/2d4695ca-5ec3-4658-8f46-101cec4ca41d)

Company: https://www.keypedia.com/companies/josefa-binker-md/1c733d05-e460-4971-a412-d46aefdc0e73

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6