FDA WARNING_LETTER - Bartush-Schnitzius Foods Co - August 22, 2011

The FDA inspected Bartush-Schnitzius Foods Co.'s seafood processing facility in Lewisville, TX, on July 20-22 and August 22, 2011, finding serious violations of seafood HACCP (21 CFR Part 123) and Current Good Manufacturing Practice (21 CFR Part 110) regulations. These violations render their seafood salad products adulterated.

Key violations include: 1. **Inadequate HACCP Plan:** The seafood salad HACCP plan lacks critical control points (CCPs) for refrigerated finished product storage (pathogenic bacteria growth) and finished product labeling (undeclared allergens). The proposed allergen control strategy (label receipt/modification) is insufficient; FDA recommends control at the label application step with finished product examination. 2. **Inadequate Critical Limits:** * The "Manufacturing of Blended Ready-to-Eat Seafood Products" CCP's critical limit for pathogenic bacteria growth is inadequate, as several pathogens are not limited by the stated (b)(4) parameter. Processing times frequently exceed (b)(4) hours, and production room temperature is not monitored. * The "Vegetable Processing" CCP's critical limit for metal inclusion ("No metal particles in excess of (b)(4) mm") is inadequate; FDA recommends "no detectable metal fragments." Monitoring frequency ("Continuous" and "Machine tested at least (b)(4)") is