FDA 483 - Diamond Pet Foods, LLC - January 19, 2006

During an inspection from December 21, 2005, to January 19, 2006, the FDA identified significant quality control and safety concerns at Diamond Pet Food Processors of South Carolina, LLC. A major issue was the detection of high aflatoxin levels in 16 batches of finished pet food products, with concentrations reaching up to 376 ppb, and in incoming whole corn shipments, one exceeding 1851 ppb. The inspection revealed critical failures in the firm's procedures for managing this contaminant. These included unreliable aflatoxin testing for incoming corn, resulting in false negatives, incomplete documentation of test results, and a lack of controls to ensure test accuracy. Furthermore, over 50% of retention samples for incoming whole corn were missing, hindering secondary verification. The company also accepted incoming ingredients like wheat flour, rice bran, and chicken by-product meal that did not meet its internal specifications for key nutritional components. Other observations included outdated written procedures for receiving materials, the absence of acceptance criteria or testing for externally stored 'fines,' and the omission of a BSE warning statement on invoices for pet food scraps sold to hog farmers. These findings indicate a need for prompt corrective actions to comply with the Federal Food, Drug, and Cosmetic Act and ensure product safety.