FDA WARNING_LETTER - Silver Moon Springs LLC - July 20, 2011

On November 7, 2011, the FDA issued a Warning Letter to Silver Moon Springs LLC following an inspection from July 19-20, 2011. The inspection revealed serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations (21 CFR Part 123) and Current Good Manufacturing Practice regulations (21 CFR Part 110). Consequently, the firm's Smoked Salmon, Smoked Trout, and Smoked Salmon Spread are deemed adulterated.

Key violations include: 1. Lack of a HACCP plan for ready-to-eat Smoked Salmon Spread to control pathogen growth and undeclared allergens (21 CFR 123.6(a) and (b)). 2. Failure to take appropriate corrective actions when critical limits were deviated from, specifically for *C. botulinum* control in smoked salmon and pathogen/parasite control in smoked trout. Corrective actions also failed to address the cause of failures (21 CFR 123.7(a)). 3. Inadequate critical limits in HACCP plans for Smoked Salmon and Smoked Trout, specifically regarding (b)(4) conditions for pathogen growth and toxin formation (21 CFR 123.6(c)(3)). 4. Failure to verify the adequacy of critical limits for Smoked Salmon and Smoked Trout, with analytical results showing insufficient