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

Source: https://www.keypedia.com/records/eir/sandor-a-romero-md/ff0e5b22-b089-4a52-a11b-04217146d2d7

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

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## Details

- Record Type: EIR
- Company Name: Sandor A. Romero, MD
- Inspection Date: 2018-02-13
- Product Type: Drugs
- Office Name: Office of Scientific Investigations
- Summary: An FDA For Cause Inspection was conducted at the clinical investigator site of Dr. Sandor A. Romero, MD, in Cutler Bay, FL, from February 2 to February 13, 2018. The inspection, carried out under Compliance Program 7348.811 for Bioresearch Monitoring, focused on a specific clinical study involving 26 randomized subjects.
The primary and significant violation identified was the 'Failure to prepare or maintain adequate and accurate case histories.' Dr. Romero was unable to provide FDA investigators access to the Electronic Data Capture (EDC) system, which served as the primary repository for critical source data. This inaccessible data included information on adverse events, safety laboratory reports, physical examinations, investigational product compliance, and dose titration, thus preventing verification of study conduct and adherence to the protocol. This finding cites a violation of 21 CFR 312.62(b).
Upon discussion, Dr. Romero acknowledged the observation, attributing the lack of EDC access to the site's closure by the sponsor. He committed to establishing procedures to ensure continuous access to both electronic and hardcopy source data in future studies. Dr. Romero was issued an FDA Form 483, Inspectional Observations, and was advised to provide a written response to the agency within 15 business days. The FDA also informed him that these findings might lead to further administrative actions.

## Related Documents

- [483 - 2018-02-13](https://www.keypedia.com/records/483/sandor-a-romero-md/b2a3668b-3289-4507-914a-37f4669c7d02)

## Related Officers

- [recipient](https://www.keypedia.com/people/sandor-a-romero/8ade384c-f337-43ed-a8a0-ba78278a4402)
- [Richard A. Lyght](https://www.keypedia.com/people/richard-a-lyght/8d60b5c0-4acd-4abc-979a-fb4b3e82964d)

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

Office: https://www.keypedia.com/offices/office-of-scientific-investigations/c53ddaca-0613-4f9d-8f84-8113696f359d