FDA WARNING_LETTER - computer times publishing inc. - September 21, 2012

On February 12, 2013, the FDA issued a Warning Letter to Computer Times Publishing, Inc. dba Sushi Chef, following an inspection from September 11-21, 2012, at their Honolulu, Hawaii facility. The inspection revealed serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations (21 CFR Part 123) and Current Good Manufacturing Practice (GMP) regulations (21 CFR Part 110).

Violations included adulterated refrigerated, ready-to-eat tuna sandwiches and sushi seafood products due to insanitary conditions, and other ready-to-eat products (chicken salad, egg salad sandwiches, sushi, rice, and bento) adulterated under 21 U.S.C. § 342(a)(4) for being prepared, packed, or held under insanitary conditions.

Specific HACCP deficiencies included: * Failure to list scombrotoxin (histamine) formation as a hazard in tuna sandwich HACCP plans. * Failure to list undeclared allergens and food intolerance substances as hazards in HACCP plans for tuna sandwiches and sushi. * Failure to list critical control points for mixing ingredients and staging/sorting to control pathogen growth and toxin formation due to time/temperature abuse in ready-to-eat products. * Failure to list a critical control point for finished product storage to control pathogen growth