FDA 483 - RadioMedix, Inc. - March 24, 2022

An FDA inspection of RadioMedix, Inc., a PET drug manufacturer in Humble, TX, revealed significant deficiencies in its operations. Observations included inadequate production and process controls, particularly concerning aseptic technique and cleanroom practices, and incomplete master production and control records. The firm also lacked proper procedures for equipment suitability, failed to prevent facility contamination, did not conduct identity testing on active ingredient components, and had an unreliable supplier qualification process.