FDA EIR - Diamond Pet Foods, LLC - April 20, 2012

Diamond Pet Food Processors of SC, LLC in Gaston, SC, underwent an FDA inspection from April 12-20, 2012. The inspection was prompted by a 'Diamond Naturals' Lamb and Rice Dog Food sample testing positive for *Salmonella infantis*, which led to a voluntary product recall. Key violations, identified under the FDA regulatory framework including 21 CFR Part 110 (Good Manufacturing Practices), highlighted significant deficiencies in contamination control and facility hygiene. These included inadequate precautions to prevent contamination, such as a lack of microbiological testing for incoming animal fat, improper sampling and storage of animal digest, and an employee handling production equipment with bare hands after touching unsanitary surfaces. The facility also failed to provide necessary handwashing and sanitizing stations in direct food contact areas. Equipment maintenance was poor, with damaged conveyor paddles and non-cleanable surfaces accumulating residues, creating potential harborage for microorganisms.

In response, Diamond Pet Food Processors voluntarily halted operations for extensive cleaning and sanitization. Management committed to corrective actions, including modifying in-house testing protocols for raw materials, developing a 'kill step' for fat application, and implementing *Salmonella* testing for finished products. They also pledged to retrain staff on sanitary procedures, enhance equipment cleaning, replace damaged components, and eliminate non-cleanable materials. The company also promised to explore alternative solutions for providing hand hygiene stations and to submit a written response to the FDA's observations.