FDA 483 - Vital Care Compounder, Inc - October 13, 2022

An FDA inspection of Pharmacy Plus, Inc. dba Vital Care Compounder in Hattiesburg, MS, revealed significant deficiencies in the production of sterile and non-sterile drug products. Observations included microbial contamination in aseptic areas, inadequate sterilization processes, poor facility and personnel aseptic practices, and insufficient media fills. These issues indicate a high risk of product contamination and compromise of sterility assurance.