FDA WARNING_LETTER - Spence & Co., Ltd. - November 28, 2012

On January 15, 2013, the FDA issued a Warning Letter to Spence & Co., Ltd. following an inspection from November 7-28, 2012, at their Brockton, MA seafood processing facility. 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 was the firm's failure to have a HACCP plan with adequate critical limits, rendering their cold smoked salmon products adulterated under 21 U.S.C. § 342(a)(4). Specifically, the revised HACCP plans for cold smoked salmon and gravalox listed a bacteriophage application as a critical limit for controlling *Listeria monocytogenes*, but the firm could not provide a validated study demonstrating its effectiveness. This is particularly concerning given two voluntary recalls in August and November 2012 due to *Listeria monocytogenes* contamination in finished products.

Additionally, the HACCP plans' critical limits for curing (e.g., "medium salt coverage") were inadequate to control pathogen growth and toxin formation, including *Clostridium botulinum*. The plans lacked specific details like the required amount of salt and standardized product sizes, which are typically established during a validation study to ensure a minimum of 3.5% water