FDA 483 - Afton Scientific, LLC - June 14, 2019

Afton Scientific LLC, a drug manufacturer in Charlottesville, VA, was inspected by the FDA and cited for multiple deficiencies. The inspection revealed significant issues in aseptic processing validation, laboratory controls, and drug product storage conditions. Additionally, the firm failed to adequately manage electronic records, prevent contamination in sterile areas, and thoroughly investigate product complaints and environmental monitoring discrepancies.