# FDA 483 - Blanca Gonzalez, M.D. - January 23, 2020

Source: https://www.globalkeysolutions.net/records/483/blanca-gonzalez-md/b7032420-ca33-4141-86a9-8908deafcf40

> FDA 483 for Blanca Gonzalez, M.D. on January 23, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Blanca Gonzalez, M.D.
- Inspection Date: 2020-01-23
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Blanca Gonzalez, M.D. in Miami Lakes, FL, revealed significant deficiencies in the conduct of a clinical investigation. Observations included failures to follow the signed statement of investigator, inadequate investigational drug disposition records, and a lack of accurate case histories. These issues collectively point to problems with data integrity and adherence to study protocols.

## Related Officers

- [Angelica M. Chica](https://www.globalkeysolutions.net/people/angelica-m-chica/117a5aa3-e5ed-46f2-bf32-885591c34848)

Company: https://www.globalkeysolutions.net/companies/blanca-gonzalez-md/26f9ac08-394c-4577-905c-5c55e6078653

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