FDA 483 - Family Pharmacy of Statesville - February 12, 2020

Family Pharmacy of Statesville was inspected and cited for multiple deficiencies in both sterile and non-sterile drug production. Key issues include inadequate aseptic processing controls, lack of endotoxin testing for intrathecal products, facility design flaws, and insufficient quality control for water and equipment calibration. These observations indicate significant concerns regarding the sterility assurance and overall quality of drug products manufactured at the facility.