FDA WARNING_LETTER - Willamette Shelling Inc - December 09, 2009

The FDA inspected Willamette Filbert Growers, Inc.'s hazelnut processing facility in Newberg, Oregon, on November 17-20, 2009, with a follow-up on November 30 to December 9, 2009. Environmental samples tested positive for Salmonella, including on food contact surfaces, leading to the classification of manufactured foods as adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Six environmental samples tested positive for Salmonella species; two were from food contact surfaces (plastic curtains, scraper/rake face), and two were near exposed food or food contact surfaces (power cable, grading drum plastic covering). PFGE analysis linked Salmonella from the plastic curtains and power cable/grading drum covering to Salmonella isolates found in the firm's finished hazelnut kernels by the Oregon Department of Agriculture (ODA).

Additional CGMP violations (21 CFR 110) included evidence of rodent and insect activity, residual organic matter on plastic curtains, and inadequate sanitation practices. Specific observations included an employee stepping near a hazelnut kernel spout with shoes, and uncovered metal totes with cobwebs and dirt stacked above other uncovered totes.

The firm initiated a recall of shelled hazelnuts processed from October 12 to November 25, 2009, and responded to the FDA on November 23, 2009, addressing some observations. The FDA acknowledged