FDA WARNING_LETTER - Nachman's Native Seafood - November 05, 2010

The FDA inspected Nachman's Native Seafood from October 28 to November 5, 2010, identifying serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and Current Good Manufacturing Practice (21 CFR Part 110). The firm's ready-to-eat Smoked Fish Spread was deemed adulterated due to insanitary conditions.

Key violations include: 1. **Failure to implement record-keeping system (21 CFR 123.6(b) and (c)(7)):** No monitoring records were available for receiving, thawing, cooking, or refrigerated storage critical control points for fresh fish, smoked fish, or smoked fish spread. 2. **Insufficient monitoring of sanitation conditions (21 CFR 123.11(b)):** * **Cross-contamination risk (21 CFR 123.11(b)(3)):** Organic matter buildup on a grinder/mixer, organic buildup and mildew in an ice storage tote, and mildew accumulation on walls, ceilings, vinyl strips, and cooling fans were observed. * **Facility construction and maintenance (21 CFR 110.20(b)(4)):** Chipping paint on a wall, holes exposing plumbing and electrical fixtures, and a restroom door not self-closing were noted.

The FDA acknowledged voluntary