FDA WARNING_LETTER - Basic Food Flavors, Inc. - March 04, 2010

The FDA conducted an inspection of Basic Food Flavors, Inc.'s facility in North Las Vegas, NV, from February 12 to March 4, 2010, focusing on hydrolyzed vegetable protein (HVP) production. The inspection revealed that HVP processed by the firm was adulterated. Laboratory analysis of a finished HVP product sample found *Salmonella tennessee*, rendering it adulterated under Section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) due to containing a poisonous substance. Environmental samples also tested positive for *Salmonella* (including *S. tennessee*, *S. senftenberg*, and *S. westhampton*) in nine locations, with *S. tennessee* matching the finished product strain, indicating an established niche environment and high contamination risk. This led to a determination that HVP products were adulterated under Section 402(a)(4) due to insanitary conditions. Additionally, the inspection identified serious violations of the Current Good Manufacturing Practice (CGMP) regulation for foods (21 CFR Part 110). The firm initiated a voluntary recall of HVP manufactured on or after September 17, 2009, and submitted a response outlining corrective actions, including new procedures, training, and program revisions. FDA requires documentation of these implemented corrections, details on minimizing contamination risks, monitoring plans, and employee training materials within 15 working days. Failure to adequately address these violations may result in further regulatory actions like seizure or injunction.