FDA 483 - Sunland, Inc. - October 25, 2007

This FDA Form 483 documents observations from an inspection of a facility manufacturing ready-to-eat Organic Creamy Peanut Butter and processing peanuts. The inspection revealed multiple failures to maintain sanitary conditions and prevent contamination.

Key violations include: - **Direct product contamination risks:** An employee placed fingers inside empty jars, a supervisor handled cap interiors without sanitizing hands, and a filler operator reused an unsanitized spatula and paper towel. - **Equipment and facility sanitation issues:** A grinder leaked peanut butter onto the floor, a (b)(4) leaked peanut butter from pistons and gaskets, uncapped process pipes touched the floor, and a hand wash sink lacked soap and paper towels. Duct tape was used for repairs on equipment. - **Employee hygiene failures:** Employees were observed entering and exiting process areas without adequate hand washing and sanitizing. - **Pest control deficiencies:** Pallets were stored too close to walls, rodent traps were missing or blocked, and a loading dock door was propped open. - **Raw material storage issues:** Damaged bags of peanuts were stored, opened and uncovered boxes of raisins, dried cranberries, and a torn almond tote were found. Product spillages, including allergens, were not cleaned. Opened bags of various ingredients were stored unprotected. - **Building maintenance:** A two-inch hole was present in a wall in the peanut warehouse.

These observations indicate a failure to manufacture foods under conditions that minimize microorganism growth and contamination, ensure production