FDA WARNING_LETTER - Sunburst Trout Company, LLC - July 19, 2012

On July 17-19, 2012, the FDA inspected a seafood processing facility at 128 Raceway Place in Canton, NC, identifying 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). Failure to comply renders fish or fishery products adulterated under 21 U.S.C. § 342(a)(4), meaning smoked fish products were prepared, packed, or held under insanitary conditions. A FORM FDA 483 was issued on July 19, 2012, but no written response was received.

Significant violations include: 1. **Inadequate HACCP Plan for Cold Smoked Trout:** The plan failed to list cooler storage as a critical control point for pathogen growth and toxin formation during in-process cold storage, violating 21 CFR 123.6(a) and (c)(2). FDA recommends continuous temperature monitoring. 2. **Inadequate Monitoring Procedures for Hot Smoked Trout:** The HACCP plan's monitoring frequency for cooler storage was insufficient (21 CFR 123.6(c)(4)). While a temperature recorder was present, records showed at least ten instances of charts not being checked or replaced for up to four weeks, leading to data overlaps. Additionally, the