FDA WARNING_LETTER - ECRS, LLC - August 10, 2011

The FDA inspected ECRS, LLC dba Big Chef's seafood processing facility in Hollywood, FL, from July 25 to August 10, 2011, and found 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 ready-to-eat (RTE) salmon pinwheels, RTE seared tuna canapés, RTE cooked scallops with avocado salad canapés, and RTE surimi-based canapés 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 RTE refrigerated salmon pinwheels and RTE refrigerated tuna canapés, as required by 21 CFR 123.6(a) and (b). Additionally, the HACCP plans for "SCALLOPS COOKED" and "SURIMI (IMITATION CRAB)" were deficient, failing to list all reasonably likely food safety hazards, such as pathogenic bacteria survival/growth and Clostridium botulinum growth/toxin formation, at critical control points including cooking, cooling, thawing, and finished product storage, violating 21 CFR 123.6(c)(1). The firm's August 15, 2011, response to the FDA 483 was inadequate due to a lack of supporting documentation for planned corrective actions. The FDA requires a written response within fifteen working days, detailing specific corrections with supporting documentation. Failure to promptly correct these violations may result in further action, including product seizure and/or an injunction against the firm.