# FDA 483 - Sandor A. Romero, MD - February 13, 2018

Source: https://www.globalkeysolutions.net/records/483/sandor-a-romero-md/b2a3668b-3289-4507-914a-37f4669c7d02

> FDA 483 for Sandor A. Romero, MD on February 13, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sandor A. Romero, MD
- Inspection Date: 2018-02-13
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Sandor A. Romero, MD in Cutler Bay, FL, a clinical investigator, revealed a significant issue regarding the maintenance of adequate and accurate case histories. Specifically, the firm failed to provide source data for verification, which was committed to by signing the FDA 1572 Statement of Investigator. This deficiency impacts the integrity and accuracy of study data, including adverse event reporting and investigational product compliance.

## Related Documents

- [EIR - 2018-02-13](https://www.globalkeysolutions.net/records/eir/sandor-a-romero-md/ff0e5b22-b089-4a52-a11b-04217146d2d7)

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/sandor-a-romero-md/16839dfc-3e36-42fb-8562-ded2c306d3a7

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