FDA 483 - Rosa Maria Jimenez Rodriguez, M.D.,Ph.D. - December 20, 2024

An FDA Form 483 was issued to Rosa Maria Jimenez Rodriguez, M.D., Ph.D., a Clinical Investigator located in Sevilla, Spain, following an inspection conducted from December 16-20, 2024. The document details observations made by the FDA during their assessment of a specific study protocol.

The primary observation cited was a "Failure to prepare or maintain adequate case histories with respect to observations and data pertinent to the investigation." This indicates deficiencies in essential record-keeping for the clinical investigation.

Specifically, the inspection revealed that the site did not maintain proper records demonstrating appropriate storage of prepared investigational product (IP) infusions prior to administration. For example, source records lacked documentation on whether prepared IP infusions were stored at ambient temperatures or refrigerated, a critical detail given the six-hour ambient storage limit. Furthermore, one subject's doses were not administered according to the IP manual over an extended period. Another significant issue highlighted was the incorrect calculation of a subject's screening APACHE II score, which led to improper stratification.

As an FDA Form 483, these are inspectional observations that do not represent a final agency determination of compliance. However, the regulatory framework requires the firm to address these findings. The firm has the opportunity to discuss objections or submit information regarding implemented or planned corrective actions to the FDA, which are crucial to ensure adherence to regulatory standards for clinical investigations.