FDA WARNING_LETTER - Edo Sushi Express - September 15, 2015

An FDA inspection of Edo Sushi Express, Inc. on September 9, 10, and 15, 2015, revealed serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations (21 CFR Part 123) and Current Good Manufacturing Practice (cGMP) regulations (21 CFR Part 110). Consequently, the firm's ready-to-eat seafood sushi rolls are deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Key violations include failure to implement HACCP monitoring procedures and frequencies (21 CFR 123.6(b) and (c)(4)), lack of critical limits for allergens in the HACCP plan (21 CFR 123.6(c)(3)), and inadequate sanitation control records (21 CFR 123.11(c)). Additionally, products were adulterated due to unsafe food additives (aspartame, sodium saccharin) with improper labeling, such as missing phenylketonurics statements or undeclared amounts per serving (21 U.S.C. § 342(a)(2)(C)(i), 21 CFR 172.804(d)(2), 21 CFR 180.37). Numerous misbranding issues were identified, including failure to declare major food allergens correctly (e.g., eggs) (21 U.S.C. § 343(w)), improper nutrition information format (21 U.S.C. § 343(q), 21 CFR 101.9), undeclared sub-ingredients (21 U.S.C. § 343(i)(2), 21 CFR 101.4), use of incorrect common names for ingredients, and misleading "may contain" statements. Other misbranding issues involved inconsistent allergen declarations, non-adjacent "Contains" statements, incomplete product names, and missing manufacturer/distributor address information (21 CFR 101.5(d)). The firm must respond within fifteen working days, detailing corrective actions with supporting documentation. Failure to comply may result in product seizure, injunction, and re-inspection fees.