FDA EIR - Jose Carlos Lopez Escobar, M.D. - July 03, 2024

An FDA inspection of Jose Carlos Lopez Escobar, M.D., operating as Health Care Family Rehab and Research Center in Hialeah, FL, was conducted from June 24 to July 3, 2024. This was a comprehensive, for-cause clinical investigator inspection under Compliance Program 7348.811, focusing on bioresearch monitoring. The inspection revealed significant concerns, culminating in the issuance of an FDA Form 483, Inspectional Observations. The primary observation cited a "Failure to prepare or maintain adequate case histories with respect to observations and data pertinent to the investigation." Specifically, five out of seven reviewed subjects in one protocol lacked sufficient documentation to confirm compliance with inclusion criteria regarding a stable dose of an approved disease treatment for a specified duration prior to screening, as required by 21 CFR 312.62(b). Beyond the formal observation, additional issues were discussed with management. These included instances where corrected lab reports were signed with dates prior to the reported date, ECGs and lab reports were signed as reviewed by Dr. Lopez but not adequately evaluated for significance, and a lab report was missing. Furthermore, problems were identified with a sponsor-provided continuous temperature monitoring device for investigational products, leading to delayed data review and affecting dispensed study medication. Management, represented by Ms. Amanda G. Colina, acknowledged the observations and discussion items. She committed to providing a written response within 15 business days. The facility plans to review active study subjects for safety assessment evaluations and update standard operating procedures for investigational product temperature monitoring. The FDA informed the site that observed conditions might constitute violations of the FD&C Act, potentially leading to administrative actions, injunctions, civil money penalties, or prosecution.