FDA WARNING_LETTER - Gold State Nut LLC - May 06, 2015

On November 10, 2015, the FDA issued a Warning Letter to Gold State Nut LLC following a joint inspection with the CDPH from April 22 to May 6, 2015. The inspection of the walnut processing facility revealed the presence of *Salmonella* and multiple Current Good Manufacturing Practice (CGMP) violations, rendering the walnuts adulterated under 21 U.S.C. 342(a)(4).

FDA laboratory analysis found *Salmonella* in three of 100 environmental swabs, including one from a cross-beam directly above the shelled walnut exit belt, where debris was observed falling onto the product. Two swabs from a reptile enclosure in the office also yielded *Salmonella*. The President was observed handling a bearded dragon and then touching shelled walnuts without washing hands, and reptiles are known *Salmonella* reservoirs.

CGMP violations included: 1. Failure to protect against contamination (21 CFR 110.10(b)(9)): Observed handling a reptile then walnuts without handwashing, an employee tracking standing water into the shelling room, and a shovel in contact with the floor and shelled walnuts. 2. Improper handling of containers (21 CFR 110.80(b)(7)): In-shell walnut bins in standing water, creating cross-contamination potential. 3. Inadequate cleaning of non-food contact surfaces (21 CFR