# FDA 483 - Maria A. Carballosa MD - August 26, 2021

Source: https://www.globalkeysolutions.net/records/483/maria-a-carballosa-md/91cd8f16-7a44-4f5f-a3a5-28cc0b885453

> FDA 483 for Maria A. Carballosa MD on August 26, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Maria A. Carballosa MD
- Inspection Date: 2021-08-26
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Maria A. Carballosa, Clinical Investigator, in Hialeah, FL, revealed significant deviations from the investigational plan for a clinical study. The firm enrolled subjects who did not meet inclusion criteria and incorrectly dosed multiple subjects with the investigational product. These findings indicate a failure to adhere to study protocol requirements.

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