FDA WARNING_LETTER - CTI Foods, LLC - September 21, 2012

On September 5-21, 2012, the FDA inspected CTI Foods, LLC's seafood processing facility in Saginaw, Texas, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). The firm's lobster bisque, clam chowder, and seafood gumbo soups are deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Despite the firm's response and submitted documentation, significant violations persist. CTI Foods' revised HACCP plan for lobster bisque soup fails to list critical control points (CCPs) for tempering (thawing) raw lobster, hot filling, container integrity, and refrigerated finished product storage to control *Clostridium botulinum*. The plan also lacks adequate critical limits for the cook step, with the stated time and temperature (b)(4)°F for (b)(4) minutes being insufficient to control *Clostridium botulinum*. Furthermore, the HACCP plan for lobster bisque soup does not specifically list *Clostridium botulinum*, metal inclusion, undeclared allergens, and food intolerance substances as reasonably likely food safety hazards, instead broadly listing "biological." The firm's thawing and storage temperatures for lobster bisque and the labeling for frozen clam chowder and seafood gumbo soups also do not align with FDA guidance for controlling *Clostridium botulinum*.

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