FDA 483 - Northern VA Compounders PLLC - December 09, 2022

An FDA inspection of Northern VA Compounders PLLC in Sterling, VA, revealed significant deficiencies in both sterile and non-sterile drug production. Key issues included inadequate measures to prevent cross-contamination, the use of non-pharmaceutical grade components, and poor environmental controls within aseptic processing areas. These observations highlight a lack of adherence to proper manufacturing practices, potentially compromising drug product quality and patient safety.