FDA 483 - Gateway America LLC - January 17, 2020

Gateway America LLC, a manufacturer of pet treats in Gulfport, MS, was cited for significant deficiencies in its hazard analysis and preventive controls. The firm failed to evaluate known or foreseeable hazards, specifically for a fumigation step added to certain pet treats. Additionally, it did not implement preventive controls to minimize or prevent hazards associated with these fumigated products.