Newman's Fish Markets, Inc. – FDA Warning Letter, Aug 23, 2010

On August 19, 20, and 23, 2010, the FDA inspected a seafood processing facility at 2601 N. Newark Street, Suite E, Portland, Oregon, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation for foods (21 CFR Part 110). The firm's hot smoked, vacuum-packaged, refrigerated salmon, sturgeon, escolar, tuna, and black cod were deemed adulterated due to insanitary conditions.

Key violations include: 1. **Lack of HACCP Plan:** The firm lacked a HACCP plan for hot smoked, vacuum-packaged refrigerated sturgeon to control *Clostridium botulinum* and environmental chemical contaminants (21 CFR 123.6(a) and (b)). The firm's proposed freezing and labeling changes were unclear regarding product use and *Clostridium botulinum* control. 2. **Failure to Take Corrective Action:** The firm failed to take appropriate corrective action when critical limits were exceeded. This occurred for *Clostridium botulinum* when hot smoked, vacuum-packed, refrigerated salmon did not reach the required internal temperature of (b)(4) °F for (b)(4) minutes at the Smoking/Cooking CCP. Additionally, for histamine control, the refrigerated storage critical