FDA 483 - Ivan Carreras M.D./Clintex Research Group, Inc. - August 23, 2024

During an inspection conducted by the U.S. Food and Drug Administration (FDA) from August 19 to August 23, 2024, at Ivan Carreras M.D./Clintex Research Group, Inc., an FDA Form 483 was issued detailing an observed objectionable condition. The inspection, which focused on the firm's operations as a Clinical Investigator involved in bioequivalence (BA/BE) studies, identified a critical issue regarding the retention of investigational product samples. The primary observation noted was the firm's failure to retain the required quantities of both test article and reference standard samples. This is a direct violation of federal regulation 21 CFR Part 320.63, which mandates the retention of such samples to ensure the integrity and verifiability of bioequivalence study data. Specifically, FDA investigators found that for a shipment of investigational product kits received on November 28, 2022, no retention samples were selected or maintained. Furthermore, a subsequent shipment received on December 14, 2022, had only a limited number of kits retained, falling short of the regulatory requirements. These deficiencies are critical as proper sample retention is fundamental for regulatory oversight and potential re-evaluation of study materials. The issuance of this FDA Form 483 serves to formally communicate these observations to Ivan Carreras M.D., Clinical Investigator, and requires the firm to address these findings and implement comprehensive corrective and preventive actions to ensure full compliance with the pertinent federal regulations.