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 critical deficiencies across its PET drug manufacturing operations. The firm's quality unit lacked adequate oversight, failing to review environmental monitoring and cleaning records, and maintaining inaccurate SOPs. Additionally, the facility demonstrated inadequate production and process controls, including unvalidated hold times and media fill studies that did not simulate worst-case conditions, alongside the use of non-sterile disinfectants in critical aseptic areas. These findings indicate a significant risk to the quality, purity, and sterility of the PET drug products manufactured.