FDA 483 - GERRESHEIMER PEACHTREE CITY LP - December 12, 2022

An FDA inspection of GERRESHEIMER PEACHTREE CITY LP in Peachtree City, GA, a drug manufacturer, revealed significant deficiencies in quality control and manufacturing processes. Observations included inadequate investigations for product failures, insufficient microbiological testing of water used in manufacturing, and a failure to properly qualify and audit component suppliers. These issues indicate a lack of robust controls to ensure drug product quality and safety.