FDA WARNING_LETTER - Sogo Foods Inc. - October 05, 2010

An FDA inspection of Sogo Foods Inc. in San Jose, California, conducted in September and October 2010, revealed that the firm's Organic Sweetened Soy Bean Drink and Plain Pressed Tofu products are misbranded and adulterated. The misbranding violations, under Section 403 of the Act, include failure to label products on retail packages, not declaring soy as a major food allergen (403(w)), making unverified nutrient content claims like "High Protein" and "Low Calorie" (403(r)(1)(A)), lacking a statement of identity (403(i)(1)), failing to list all ingredients (403(i)(2)), omitting the manufacturer's name/place of business and net quantity of contents (403(e)), and failing to provide accurate nutrition information (403(q)). The products are also adulterated under Section 402 of the Act due to significant Current Good Manufacturing Practice (CGMP) violations (21 CFR Part 110). These include inadequate production procedures leading to contamination (21 CFR 110.80), poorly maintained and cleaned equipment (21 CFR 110.80(b)), and severe deficiencies in personnel hygienic practices (21 CFR 110.10(b)), such as soiled aprons, improper handwashing, lack of hair restraints, and drinking in processing areas. Further CGMP issues involve unsanitary plant facilities with mold-like growth, pooling water, dripping condensate, and dirty fans (21 CFR 110.35(a), 21 CFR 110.20(a)), and a rusty, non-food-grade tofu grinder (21 CFR 110.40(a)). The FDA requires a written response within 15 working days detailing corrective actions, supporting documentation, and timelines to prevent recurrence, warning that failure to comply could lead to regulatory actions like seizure or injunction.