Afton Scientific, LLC – FDA 483, Oct 22, 2021

Afton Scientific LLC, a drug manufacturer in Charlottesville, VA, was cited for significant deficiencies during an FDA inspection. Observations included poor maintenance of Class A aseptic processing areas, leading to potential contamination and mix-ups of injectable drug products like Cortrophin Gel. Additionally, the firm failed to establish the accuracy, sensitivity, specificity, and reproducibility of test methods used to determine extractable compounds in Cortrophin Gel, and did not ensure analytical test methods were validated and GMP compliant.