FDA WARNING_LETTER - Blossom Enterprises LLC - November 21, 2011

On February 7, 2012, the FDA issued a Warning Letter to Blossom Enterprises LLC dba Sea Blossom Seafoods following an inspection on November 8, 9, and 21, 2011. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation (21 CFR Part 110).

The primary violation identified was an inadequate HACCP plan for "VacPak products processed between (b)(4) Deg F and (b)(4) deg F for (b)(4) minutes." Specifically, the critical limits for "Smoking temperature above (b)(4) Deg F and below (b)(4) Deg F for (b)(4) minutes" at the Cold Smoking Critical Control Point were deemed insufficient to control pathogen growth and toxin formation, particularly *Listeria monocytogenes*. The smoked salmon product did not reach temperatures sufficient to destroy pathogens (e.g., 145°F for 30 minutes for hot smoked) nor was it consistently maintained below 90°F for cold smoked products.

The FDA acknowledged the firm's December 12, 2011, response to the FDA 483, which proposed adding salting and washing times as controlling factors and using (b)(4) to address *Listeria* concerns. However