Valley Proteins, Inc – FDA Warning Letter, Apr 22, 2019

The FDA conducted inspections of a rendering plant in Winchester, VA, on February 5-6 and April 3, 22, 2019, identifying significant violations of the Federal Food, Drug, and Cosmetic Act. The plant produces animal food ingredients.

A key violation was the adulteration of animal fat products with pentobarbital, an unsafe new animal drug without an established tolerance in animal tissues. An FDA sample collected on November 14, 2018, from a finished fat tank confirmed pentobarbital contamination. The firm's response, claiming pentobarbital as an "unavoidable contaminant," was deemed inadequate, as it is the firm's responsibility to prevent such adulteration.

Additionally, the plant violated FDA's Current Good Manufacturing Practice (CGMP), Hazard Analysis, and Risk-Based Preventive Controls (PCAF) requirements (21 C.F.R. part 507). Specifically, the firm failed to identify pentobarbital as a known or reasonably foreseeable hazard in its Animal Food Safety Plan, despite receiving raw materials from animals likely euthanized chemically.

Upon discovering contamination on December 18, 2018, the firm failed to notify customers or recall the product, contrary to its own recall plan. The FDA inquired about a recall multiple times, but the firm declined, stating no legal requirement. While cleaning and testing began in January 2019, the firm did not address distributed adulterated product