Santos Incorporated – FDA Warning Letter, Mar 23, 2012

An FDA inspection of Santos Incorporated in San Leandro, California, conducted from March 8 to March 23, 2012, revealed serious violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110) and misbranding issues under Section 403 of the Federal Food, Drug, and Cosmetic Act. These deficiencies render the firm's food products adulterated and misbranded. CGMP violations included inadequate cleaning and sanitizing of equipment and utensils (21 CFR 110.80(b)(1), 110.35(d)), poor employee hygienic practices and handwashing (21 CFR 110.10(b)(3), 110.10(b)(5)), use of non-cleanable equipment and work surfaces (21 CFR 110.40(a), 110.40(c)), and lack of adequate handwashing facilities near the repackaging area (21 CFR 110.37(e)(1)). Labeling violations for products like "All Purpose Flour (Maida)" included failure to declare the major food allergen, wheat (Section 403(w)), misbranding by using an incorrect product name (Section 403(b)), failure to declare all ingredients (Section 403(i)(2), 21 CFR 101.4), and absence of a nutrition facts panel (Section 403(q), 21 CFR 101.9). The firm had voluntarily recalled products due to allergen cross-contamination but had not provided a written response to the FDA 483 observations. Santos Incorporated must respond in writing within 15 working days, detailing corrective actions, prevention plans, and a timeline. Failure to comply may result in legal action, including product seizure and injunction.