FDA WARNING_LETTER - Garden-Fresh Foods, Inc. - November 19, 2009

On November 16-19, 2009, the FDA inspected Garden-Fresh Foods, Inc.'s seafood processing facility in Milwaukee, Wisconsin, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). These violations render products like Tuna Salad, Shrimp Scampi Dip, Creamy Seafood Salad, and Smoked Salmon Dip adulterated under 21 U.S.C. § 342(a)(4) because they were prepared, packed, or held under insanitary conditions.

Key violations include: 1. Failure to conduct a proper hazard analysis and list critical control points: The firm's HACCP plan for Seafood Salad Products did not identify thawing/storage of vacuum-packed surimi as a critical control point to control *Clostridium botulinum* growth and toxin formation, despite a lengthy thawing process. (21 CFR 123.6(a) and (c)(2)) 2. Inadequate monitoring procedures: The HACCP plan for Seafood Salad Products lacked an appropriate monitoring frequency for the "Storage of Finished Products" critical control point to control pathogen growth. Intermittent temperature checks were deemed insufficient. (21 CFR 123.6(c)(4))

The FDA warns that failure to promptly correct these violations may result in further action, including product seizure and/or injunction against the firm'