# FDA 483 - Evelyn Lopez-Brignoni, M.D. - June 23, 2020

Source: https://www.globalkeysolutions.net/records/483/evelyn-lopez-brignoni-md/ab946697-f517-4ccb-a5d2-8af4c4d0bd95

> FDA 483 for Evelyn Lopez-Brignoni, M.D. on June 23, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Evelyn Lopez-Brignoni, M.D.
- Inspection Date: 2020-06-23
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Evelyn Lopez-Brignoni, M.D., a clinical investigator in Palmetto Bay, FL, was cited for significant deviations during clinical studies. The firm failed to conduct investigations in accordance with the investigational plan, including issues with investigational product dosing, subject inclusion criteria, and pharmacokinetic blood sample collection. Additionally, the firm did not prepare or maintain accurate case histories, specifically regarding investigational product compliance calculations.

## Related Documents

- [WARNING_LETTER - 2020-06-23](https://www.globalkeysolutions.net/records/warning_letter/evelyn-lopez-brignoni-md/010bc065-e395-4231-a40d-21577a55d807)

## Related Officers

- [Angelica M. Chica](https://www.globalkeysolutions.net/people/angelica-m-chica/117a5aa3-e5ed-46f2-bf32-885591c34848)

Company: https://www.globalkeysolutions.net/companies/evelyn-lopez-brignoni-md/0b5da1f7-b112-448b-8252-bdd929caf34c

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