FDA 483 - GenTrac, Inc. - September 12, 2019

GenTrac, Inc., a drug substance manufacturer in Middleton, WI, was inspected by the FDA from September 4-12, 2019, and received a Form 483 with six observations. The observations highlight significant concerns regarding process control deviations, inadequate cleaning procedures, poor stability sample management, gaps in maintenance event handling, incomplete equipment qualifications, and facility sanitation issues. These findings indicate a need for improved quality system oversight and adherence to established procedures.