FDA EIR - Integrity Clinical Research Center, Inc. - April 18, 2024

An FDA inspection of Integrity Clinical Research Center, LLC (ICRC) in Hialeah, FL, was conducted from April 15 to April 18, 2024. As a biopharmaceutical clinical facility conducting FDA-regulated research, ICRC operates under the Federal Food, Drug, and Cosmetic (FD&C) Act. This was ICRC's first FDA inspection.

The inspection involved a comprehensive review of study records, including informed consents, protocols, adverse event reporting, and clinical source data. Key observations noted during the inspection included a verbalized discussion point with management concerning Good Documentation Practice related to off-site storage of investigational product retention samples, although these specific samples were not required for the assignment. Additionally, the investigator observed that the investigational product storage refrigerator lacked an active temperature monitoring device and contained employee lunches; management attributed this to a broken lunch fridge and medication being from closed studies. The site also did not maintain a dedicated screening and enrollment log, and the absence of a sealed randomization schedule was clarified by the sponsor as being due to dynamic randomization.

Significantly, no Form FDA 483, Inspectional Observations, was issued at the conclusion of the inspection, indicating that no formal violations were documented. While no specific corrective actions were mandated, management received a general warning regarding potential administrative actions, fines, or prosecution should future violations of the FD&C Act be identified. The inspection concluded with no refusals or samples collected.