FDA WARNING_LETTER - Central Soyfoods LLC - July 01, 2014

The FDA conducted an inspection of Central Soyfoods LLC in Lawrence, Kansas, from May 20-21 and July 1, 2014, revealing serious violations of Current Good Manufacturing Practice (CGMP) regulations, 21 CFR Part 110. These conditions render the firm's food products, including Hickory Smoked, Firm (type), and Garlic Herb Tofu, adulterated under 21 U.S.C. 342(a)(4) due to insanitary conditions. Key violations identified include: failure to effectively exclude pests (21 CFR 110.35(c)); inadequate cleaning and sanitizing procedures for equipment (21 CFR 110.35(d)(5)); failure to disassemble equipment for thorough cleaning (21 CFR 110.80(b)(1)); unsanitary food contact surfaces with rough welds (21 CFR 110.40(b)); failure to properly store equipment and control pest harborage areas around the facility (21 CFR 110.20(a)(1)); and inaccurate instruments for measuring critical conditions, specifically a thermometer discrepancy (21 CFR 110.40(f)). The FDA requires prompt corrective action to address these violations and prevent recurrence. Central Soyfoods must submit a written response within fifteen working days detailing specific corrective actions, or explaining any delays and providing timelines for completion. Failure to comply may result in regulatory actions such as seizure or injunction, and the assessment of re-inspection fees.