FDA 483 - Willamette Shelling Inc - November 20, 2009

This FDA Form 483 was issued to Willamette Shelling Inc., a hazelnut processor located at 14975 NE Tangen Rd, Newberg, OR 97132-6856, following an inspection from November 17-20, 2009. The report was issued to Mr. Paul Newell, Plant Manager.

The inspection revealed seven observations:

1. **Pest Exclusion:** Ineffective measures to exclude pests were observed. This included extensive apparent rodent excreta pellets (REPs), nesting areas, and gnawed hazelnuts in the Dry Storage Warehouse. Specific locations included stacks of old cardboard, pallets of cardboard, and wooden racks, with REPs counts ranging from 20 to over 500. Apparent urine stains were also noted. Additionally, a bent screen with a 6x6 inch opening and one-inch wide holes was found on a window of the In-Shell Warehouse.

2. **Hand Washing:** Employees did not consistently wash hands thoroughly. On November 17, 9 out of 16 employees did not wash hands before sanitizing and returning to the processing line after lunch, and 2 did not change gloves. Two of these employees had been smoking. On the same day and November 18, at least 8 employees did not wash hands before sanitizing and handling hazelnuts with bare hands after hourly breaks. At least 5 employees