FDA 483 - GenTrac, Inc. - July 30, 2025

GenTrac, Inc., a drug substance manufacturer in Middleton, WI, was cited for four observations during an FDA inspection. The findings include uncharacterized residues on equipment surfaces, inadequate microbiological recovery studies for cleaning validation, deficiencies in laboratory training and data management, and a lack of segregation of duties within the Quality Unit. These issues collectively indicate significant concerns regarding quality control, data integrity, and personnel training.