FDA WARNING_LETTER - Best Express Foods, Inc. - September 07, 2011

On December 19, 2011, the FDA issued a Warning Letter to Best Express Foods, Inc. following an inspection from August 16 to September 7, 2011. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110) and the presence of *Listeria monocytogenes*.

FDA laboratory analyses of 118 environmental swabs collected during the inspection confirmed *Listeria monocytogenes* in 26 swabs, including six from food contact surfaces. This contamination, along with observed insanitary conditions, caused the facility's foods to be adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. The company committed to voluntarily destroy specific lots of Whole Grain 3 Cheese Boat products.

Violations included: 1. Failure to minimize microorganism growth and contamination (21 CFR 110.80(b)(2)): Mold-like growth was observed on ceilings, walls, in the spiral freezer, storage freezer, and on 42 lots of frozen food products. 2. Failure to prevent contamination from drip/condensate (21 CFR 110.20(b)(4)): Water droplets and dripping were observed from the ceiling and walls above and within the spiral freezer, contaminating product conveyor equipment. 3. Failure to maintain floors, walls