483
VetGraft, LLCVetGraft, LLC – FDA 483, Nov 14, 2022
Record Details
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.
View Company Profile
ID · ce974e15-4745-4766-bc60-74a107de66f7
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.