FDA 483 - SM Rendering, Inc. - September 28, 2023

During an FDA inspection conducted from September 27-28, 2023, at SM Rendering, Inc., located at 1930 Oriskany St W, Utica, NY 13502-2920, several observations were made. Michael P. Dote is identified as the owner of this deadstock collector and processor.

The inspection revealed three key observations: 1. **Absence of a Written Food Safety Plan:** The firm lacked a written food safety plan, specifically a written Hazard Analysis that identifies and evaluates known or reasonably foreseeable hazards associated with animal tissue harvested from collected and processed deadstock. 2. **Improper Labeling of Prohibited Cattle Materials:** Three dedicated containers used for disposing of brains and spinal cords from cattle 30 months of age and older were not conspicuously labeled with the required statement "Do not feed to animals." 3. **Failure to Mark Prohibited Cattle Materials:** Brains and spinal cords removed from cattle 30 months of age and older were not marked with a denaturant, which is an agent readily detectable on visual inspection.

These observations were reported pursuant to Section 704(b) of the Federal Food, Drug and Cosmetic Act and are intended to assist the firm in complying with enforced acts and regulations.