FDA 483 - VetGraft, LLC - November 14, 2022

VetGraft, LLC, an animal drug manufacturer in Frisco, TX, was cited for significant deficiencies in its manufacturing processes for injectable PulpCyte and ArthroCyte products. The inspection revealed a pervasive lack of written procedures, process validation, adequate quality control, and stability data, raising serious concerns about product identity, strength, purity, and sterility. The firm distributed numerous units of these products without proper controls since January 2020.