FDA WARNING_LETTER - Barcelona Nut Company - March 02, 2012

The FDA inspected Barcelona Nut Company's manufacturing facility in Baltimore, MD, on February 14, 15, 21, 23, and March 2, 2012. The inspection revealed significant violations of FDA's Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110), causing the manufactured foods to be adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. §342(a)(4)].

Specific violations included: 1. Failure to clean food-contact surfaces as frequently as necessary (21 CFR 110.35(d)). Cashew pieces were observed remaining on the roasting machine belt after processing almonds, and debris from previously roasted products was found in the machine's cracks and crevices. 2. Failure to take effective measures to exclude pests and protect against contamination (21 CFR 110.35(c)). Evidence of widespread rodent activity, including numerous rodent excreta pellets (REPs) and a dead rodent, was found in shipping, finished goods storage, and raw ingredient storage areas, on and near product and pallets. Gaps in the facility allowing pest entry were noted, similar to a previous inspection in October 2009. The company's response to the recent inspection mentioned daily inspections and monthly sweeps but did not