FDA WARNING_LETTER - Karlsburger Foods, Inc. - July 19, 2010

The FDA inspected Karlsburger Foods, Inc.'s seafood processing facility from June 21-25, 29, and July 19, 2010, finding serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations (21 CFR 123) and Current Good Manufacturing Practice (21 CFR 110). Consequently, their Soup Bases (Shrimp, Lobster, Clam, Seafood, and Crab) are deemed adulterated due to insanitary conditions.

Specific HACCP violations include: 1. Failure to list "Metal" as a food safety hazard in HACCP plans for Soup Bases Fish, Shrimp/Lobster, and Clams/Shellfish. 2. Failure to list "Allergens and/or allergenic ingredients" in the HACCP plan for Soup Base Fish. 3. Failure to list "thawing" as a critical control point for controlling Clostridium botulinum growth in vacuum-packaged products. 4. Failure to list "cooling" as a critical control point for controlling pathogen growth after cooking.

Additionally, several products are misbranded: 1. Hollandaise Classic Sauce Mix and Chicken Flavor Base fail to list complete sub-ingredients for flour and (b)(4) in descending order of predominance, violating 21 CFR 101.4(b)(2). 2. Chicken Flavor Base's "