FDA WARNING_LETTER - Simply Fresh Inc. - March 12, 2008

An FDA inspection of the seafood processing facility at 918 B Pearl Street, Durham, North Carolina, on March 11-12, 2008, revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and Current Good Manufacturing Practice regulation (21 CFR Part 110). Consequently, the firm's fresh crabmeat, pasteurized crabmeat, and vacuum-packed smoked salmon are deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Key violations include the failure to conduct a hazard analysis and implement written HACCP plans for fresh crabmeat (pathogen growth), pasteurized crabmeat (pathogen growth and Clostridium botulinum toxin formation), and vacuum-packed smoked salmon (pathogen growth and Clostridium botulinum toxin formation). Additionally, the firm failed to implement and document monitoring and verification procedures for histamine development in scombrotoxin species and did not maintain sanitation control records for eight required areas. A previous response dated February 24, 2008, was deemed inadequate. The firm must respond in writing within fifteen working days, outlining specific corrective actions and providing supporting documentation, to prevent further regulatory action such as product seizure or injunction.