FDA WARNING_LETTER - BRODR. REMO AS - September 01, 2014

On March 4, 2015, the FDA issued a Warning Letter to Brodr Remo A.S. following an inspection from August 29 to September 1, 2014, which revealed violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR 123). The firm's vacuum packaged cold smoked salmon and trout products were deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

The FDA found the firm's September 16 and 17, 2014, response, including a revised HACCP plan, inadequate. Specific deviations included: 1. **Inadequate Hazard Analysis:** The revised HACCP plan for vacuum packaged cold smoked salmon and trout did not list unapproved aquaculture drugs as a reasonably likely food safety hazard (21 CFR 123.6(a) and (c)(1)). 2. **Missing Critical Control Points (CCPs):** The plan failed to list CCPs for cold storage after receiving and for cold storage of fish held on racks after cold smoking (21 CFR 123.6(a) and (c)(2)). 3. **Inadequate Critical Limits:** Critical limits at the "(b)(4)" and "(b)(4)" CCPs were insufficient to control *Staphylococcus aureus* and *Clostridium