FDA WARNING_LETTER - High Quality Organics, Inc. - March 31, 2011

On September 6, 2011, the FDA issued a Warning Letter to High Quality Organics following an inspection from March 7-31, 2011, at their Reno, Nevada facility. The inspection revealed four products—organic ground ginger, organic ground chili pepper, organic sandia chile powder, and organic ground coriander—were adulterated under Section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act due to Salmonella contamination.

The firm initiated a voluntary recall on March 10, 2011, after customers found Salmonella in "tea bag cut ginger" and "organic chili pepper ground natural." Subsequent FDA testing confirmed Salmonella in "Organic Ginger, Ground" Lot# (b)(4), "Organic Chili Pepper Ground Naturall" Lot # (b)(4), "Organic Sandia Chile Powder" Lot# (b)(4), and "Organic Coriander, Ground" Lot# (b)(4), leading to a separate recall for the coriander on April 21, 2011.

While High Quality Organics responded on April 14, 2011, with corrective actions including updated procedures for handling contaminated products, environmental sampling, and sanitation, the FDA expressed concerns. Specifically, "organic coriander, ground" tested positive for Salmonella even after steam treatment, and the firm could not provide validation for the treatment process. The updated environmental sampling plan also failed to include