# FDA 483 - Nancy Navarro Gonzalez, M.D. - July 01, 2025

Source: https://www.keypedia.com/records/483/nancy-navarro-gonzalez-md/090ff008-5059-4e2f-b106-b11845af868d

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

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## Details

- Record Type: 483
- Company Name: Nancy Navarro Gonzalez, M.D.
- Inspection Date: 2025-07-01
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of San Marcus Research Clinic, Inc. in Miami Lakes, FL, revealed critical deficiencies in record-keeping practices. For 7 out of 24 reviewed subject records, study data in source documentation was incomplete, inaccurate, not contemporaneous, and did not match the Electronic Data Capture (EDC) system, indicating severe data integrity issues.

## Related Documents

- [483 - 2025-07-01](https://www.keypedia.com/records/483/nancy-navarro-gonzalez-md/e3191800-46f7-48a5-910f-5a6ef3bdad8f)

## Related Officers

- [Ricardo Vela](https://www.keypedia.com/people/ricardo-vela/b090df1e-9d71-423a-9ec8-efaaaff5dda3)

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

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