# FDA 483 - Americo F. Padilla, MD - February 16, 2024

Source: https://www.globalkeysolutions.net/records/483/americo-f-padilla-md/72c4e23d-e4cd-4556-a21b-64437d2ce79f

> FDA 483 for Americo F. Padilla, MD on February 16, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Americo F. Padilla, MD
- Inspection Date: 2024-02-16
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Americo F. Padilla, MD in Miami, FL, a clinical investigator, revealed significant deficiencies in the conduct of clinical investigations involving children and adolescents. The firm failed to properly document parental consent for minor subjects, did not adhere to the investigational plan regarding subject eligibility and study procedures, and lacked adequate and accurate case histories with required laboratory results.

## Related Documents

- [WARNING_LETTER - 2024-02-16](https://www.globalkeysolutions.net/records/warning_letter/americo-f-padilla-md/e3c32923-62bf-4a88-8c5d-c63b4617f696)
- [WARNING_LETTER - 2024-02-16](https://www.globalkeysolutions.net/records/warning_letter/americo-f-padilla-md/4eb8c3b3-ec61-47a2-b62a-da4cda8e49c9)

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/americo-f-padilla-md/97aa63a0-d88d-41b9-bcd5-1fa99628e269

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