FDA 483 - Frederick Raal, FCP(SA), PhD - September 04, 2025

Between September 1 and September 4, 2025, the U.S. Food and Drug Administration (FDA) conducted an inspection of the clinical research facility of Dr. Frederick J. Raal in Johannesburg, South Africa. The inspection identified significant deficiencies in the management of clinical trial records for protocol LIB003-003, specifically regarding the failure to maintain accurate and complete case histories for study subjects. The primary violations involved discrepancies between original source documents and the data reported to the sponsor via the Electronic Data Capture (eDC) system. Investigators found that measurements for injection site reactions, such as swelling and redness, were reported electronically but were missing from the primary source records for several participants. Furthermore, the facility failed to accurately capture dates for adverse events, including a urinary tract infection and specific injection site reactions, leading to inconsistencies between the electronic record and the study visit logs. These observations were documented under the authority of Section 704(b) of the Federal Food, Drug, and Cosmetic Act. While these findings do not represent a final agency determination of non-compliance, Dr. Raal is required to respond to the FDA. This response should include any objections to the findings or a detailed description of corrective actions implemented to resolve the record-keeping issues and ensure future data integrity.