FDA WARNING_LETTER - Quality Plus Products, Inc. - June 09, 2010

The FDA inspected a food processing facility in Bellingham, Washington, from June 3-9, 2010, uncovering serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and Current Good Manufacturing Practice (21 CFR Part 110). As a result, the firm's refrigerated pickled herring, pickled wild salmon, and smoked salmon products are considered adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Key deficiencies included the absence of a HACCP plan for refrigerated pickled herring, and inadequate HACCP plans for "Hot Smoked Salmon" and "Pickled Wild Salmon" lacking critical control points, critical limits, and sufficient monitoring procedures. Corrective action plans for multiple products were deemed inappropriate, failing to ensure affected product control or deviation correction. Sanitation monitoring was also insufficient, with observed cross-contamination risks. Additionally, the firm lacked product specifications and affirmative steps for imported pickled herring. The FDA mandates a written response within 15 working days detailing specific corrective actions and supporting documentation, warning of potential product seizure or operational injunction if violations persist. The agency also recommended quarterly Water Phase Salt analyses for smoked salmon.