FDA 483 - Belleview 402 LLC - February 15, 2019

TG United, Inc. in Brooksville, FL, a drug manufacturer, was cited with six observations during an FDA inspection from December 2018 to February 2019. The inspection revealed significant deficiencies in quality control, including premature use of quarantined ingredients, inadequate investigation of incidents, lack of validated test methods and stability data, and insufficient controls over water systems and cleaning validation. Several observations were repeats from a previous inspection, indicating persistent issues with the firm's quality systems and manufacturing processes.