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

The FDA conducted an inspection of Dr. Sandor A. Romero's clinical research operations at the American Research Institute in Cutler Bay, FL, from February 2 to February 13, 2018. This inspection was part of a For Cause assignment by the Center for Drug Evaluation and Research (CDER) to evaluate compliance with the Bioresearch Monitoring Program. The inspection focused on a clinical study involving (b)(4) tablets.

Key issues identified during the inspection included Dr. Romero's inability to access the (b)(4) system, which housed critical source data such as physical examinations, safety laboratory reports, and adverse event reporting. This system also contained essential regulatory documents like the screening log and financial disclosures. Due to these access issues, the inspection was limited to reviewing available records, including informed consents, protocols, and medical records.

The FDA issued a Form 483 to Dr. Romero, citing a significant finding: the failure to maintain adequate and accurate case histories due to the inaccessibility of source records. Dr. Romero was informed that these observations might lead to further regulatory actions, including injunctions or fines. He was advised to respond to the FDA within 15 business days.

No samples were collected during the inspection, and there were no refusals. Dr. Romero acknowledged the findings and agreed to address the issues raised. This was Dr. Romero's first FDA inspection, and he has been involved in clinical research since 2015, previously working at other research institutes in Miami, FL.