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

An FDA inspection of Frederick J. Raal, FCP(SA), Phd, MD, a clinical investigator in Johannesburg, South Africa, from September 1-4, 2025, revealed a significant failure to maintain accurate case histories. The firm was cited for missing and inaccurately captured data in source documents for multiple study subjects, indicating serious deficiencies in data integrity and record-keeping during clinical investigations.