FDA 483 - University Of Texas MD Anderson Cancer Center: PET - February 16, 2022

The University of Texas MD Anderson Cancer Center, a PET Drug Manufacturer in Houston, TX, received a Form FDA 483 with seven observations. The inspection revealed significant deficiencies in laboratory controls, equipment suitability, data integrity, master production records, and quality unit investigations. These issues indicate a lack of adherence to good manufacturing practices for PET drug products.