# FDA 483 - Antonio E. Blanco, M.D. - January 30, 2023

Source: https://www.keypedia.com/records/483/antonio-e-blanco-md/22234e3f-380b-48e8-9637-e60a44cc9c66

> FDA 483 for Antonio E. Blanco, M.D. on January 30, 2023. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Antonio E. Blanco, M.D.
- Inspection Date: 2023-01-30
- Product Type: other
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Antonio E. Blanco, M.D. in Miami, FL, was cited with two observations during an FDA inspection as a Clinical Investigator. The firm failed to maintain adequate and accurate case histories, with multiple subjects lacking documentation to meet inclusion criteria. Additionally, the investigation was not conducted according to the signed statement of investigator and investigational plan, as subjects did not complete required study procedures or meet inclusion criteria.

## Related Officers

- [Richard A. Lyght](https://www.keypedia.com/people/richard-a-lyght/8d60b5c0-4acd-4abc-979a-fb4b3e82964d)

Company: https://www.keypedia.com/companies/antonio-e-blanco-md/ef043a91-20ad-4b64-9802-6b8a8c8f937f

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