FDA 483 - Panamerican Clinical Research Llc - August 09, 2024

During an inspection conducted from August 5-9, 2024, the Food and Drug Administration (FDA) issued a Form 483 to Christopher Romero, M.D., a clinical investigator operating at Panamerican Clinical Research Llc in Brownsville, TX. The primary observation noted was that a clinical investigation was not conducted in accordance with its approved investigational plan. The inspection revealed several critical deviations from the study protocol. Specifically, there was insufficient documentation to confirm that subjects met all inclusion criteria, particularly concerning necessary immunizations prior to enrollment. Furthermore, the investigator's review and confirmation of inclusion/exclusion criteria for multiple subjects were not adequately documented. Significant issues were also identified in the management of adverse events (AEs). Several AEs, including mild runny nose, fever, and adenopathy, were documented but not properly graded, assessed for severity, or evaluated for their relationship to the investigational vaccine, as required by the protocol. These events were also not consistently collected and reported on the appropriate data collection forms. In one instance, solicited AEs from a subject's diary were not recorded and graded in a timely manner according to the protocol. These observations highlight non-compliance with the established investigational plan, which is foundational to the regulatory framework governing clinical research and ensuring data integrity and subject safety. Christopher Romero, M.D. is required to respond to these observations with a detailed plan outlining corrective actions to prevent recurrence and ensure full adherence to study protocols and regulatory standards.