FDA 483 - NTP Radioisotopes - April 11, 2025

NTP Radioisotopes SOC Ltd., a radiopharmaceutical API manufacturer in Brits, South Africa, received a Form FDA 483 following an inspection. The observations primarily concern inadequate investigations into critical deviations and customer complaints, failure to establish timely closures for quality events, and issues with the scientific soundness and validation of test procedures. Additionally, the firm failed to establish specifications for critical raw materials.