# Nancy N. Navarro Gonzalez, M.D. – FDA 483, Jul 1, 2025

Source: https://www.keypedia.com/records/483/nancy-n-navarro-gonzalez-md/e3191800-46f7-48a5-910f-5a6ef3bdad8f

> FDA 483 for Nancy N. Navarro Gonzalez, M.D. on July 01, 2025. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Nancy N. Navarro Gonzalez, M.D.
- Inspection Date: 2025-07-01
- Product Type: other
- Office Name: Florida District Office
- Summary: An FDA inspection of San Marcus Research Clinic, Inc. in Miami Lakes, FL, revealed significant deficiencies in maintaining accurate, complete, and current subject case history records. For 7 out of 24 reviewed subject records, study data in source documentation was found to be incomplete, inaccurate, not contemporaneous, and inconsistent with the Electronic Data Capture system. These issues indicate serious concerns regarding data integrity and compliance with clinical trial regulations.

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Company: https://www.keypedia.com/companies/nancy-n-navarro-gonzalez-md/42a440df-dab7-496e-a323-64e82b9fcb92

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9