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

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.