1. You did not take effective measures to exclude pests from the manufacturing, processing, packing, and holding areas and to protect against the contamination of food on the premises by pests as required by 21 CFR 117.35(c). Specifically, during the inspection, FDA investigators noted evidence of rodent activity in the following food storage areas in your facility:My jaw has dropped TFTM (too far to measure.) Yuck.
Rodent excreta pellets (REPs) too numerous to count (TNTC) and evidence of wide spread rodent activity were identified in multiple areas throughout the plant, on raw material, and components of ready-to-eat (RTE) product. Specifically, our investigators noted REPs on the floor across from the “Sweethearts” production staging area, the floor of the “Sweethearts” cooling room, the floor of the peanut roasting room between pallets containing empty drums of “Mary Jane Peanut Butter”, in multiple locations on the floor of the raw material storage warehouse, in multiple locations on the floor of the finished product storage warehouse, the floor and storage racks of the second floor maintenance area, in multiple areas on the floor of the molding room and the loading dock. Ripped bags of sugar and ripped bags of almonds appearing to have been re-sealed were observed. Spilled sugar and almonds were observed on the floor. REPs were observed among spilled almonds on the floor.
Wednesday, May 30, 2018
Warning Letter of the Week: REP edition
Via a letter to the CEO of the New England Confectionery Company, Inc. (the makers of Necco Wafers and Sweethearts), this blistering letter: