FDA WARNING_LETTER - Visoy Food, Inc. - November 04, 2011

The FDA inspected Visoy Food, Inc., a manufacturer of tofu, soy beverages, and Chinese teas, from October 21 to November 4, 2011. The inspection identified serious Current Good Manufacturing Practice (CGMP) violations (21 CFR Part 110), leading to adulterated tofu products under 21 U.S.C. § 342(a)(4) due to insanitary conditions. Additionally, Baked Soy Bean Cake and Fried Soy Bean Cake products were misbranded under 21 U.S.C. § 343. CGMP deficiencies included failures to maintain clean equipment (21 CFR 110.80(b)), prevent cross-contamination of in-process food (21 CFR 110.35(b)(5)), properly clean and sanitize utensils (21 CFR 110.35(a)), minimize contamination from fans (21 CFR 110.20(6)), and exclude pests from processing areas. Misbranding issues involved labels lacking nutrition facts information (21 CFR 101.9). Specifically, for Fried Soy Bean Cake, serving size was not RACC-compliant (21 CFR 101.12(b)), and trans fat was undeclared (21 CFR 101.9(c)(2)(ii)). For Baked Soy Bean Cake, serving size lacked appropriate household measure (21 CFR 101.9(b)(5)(iv)), and trans fat was undeclared (21 CFR 101.9(c)(2)(ii)). The firm must implement prompt corrective actions and submit a written response within 15 working days, detailing steps taken, providing documentation, and outlining a timetable for remaining corrections. Failure to comply may result in further regulatory actions, such as product seizure or injunction.