FDA 483 - University Of Texas MD Anderson Cancer Center: PET - February 24, 2026

An FDA inspection of University Of Texas MD Anderson Cancer Center: PET in Houston, TX, revealed significant deficiencies across multiple systems. The firm's quality unit failed to adequately oversee production operations, and there were inadequate production and process controls, including unvalidated hold times and insufficient media fill studies. Additionally, facilities were found to be inadequate due to the use of non-sterile disinfectants in critical areas, and batch production records lacked essential equipment identification, collectively posing risks to PET drug quality and sterility.