FDA WARNING_LETTER - Key Ingredient Market - February 08, 2013

On June 17, 2013, the FDA issued a Warning Letter to Key Ingredient Market following an inspection from January 24 to February 8, 2013, at their Bath, PA facility. The inspection revealed serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations (21 CFR Part 123) and Current Good Manufacturing Practice (21 CFR Part 110).

The "Crab & Artichoke Spread" product was deemed adulterated because it was prepared, packed, or held under insanitary conditions and lacked a HACCP plan to control pathogen growth, toxin formation, and undeclared allergens (wheat, soy, milk, crustaceans, fish). The firm's February 25, 2013, response promising a HACCP plan by April 1 was deemed inadequate as no plan was received.

Additionally, the "Crab & Artichoke Spread" was misbranded and adulterated due to several labeling violations: * **Misleading "All Natural" claim:** The product contains synthetic ingredients (artificial flavors, sodium tripolyphosphate, tetrasodium pyrophosphate, carmine) from imitation crabmeat, rendering the "All Natural" claim false. * **Undeclared color additive:** Carmine, a color additive and allergen, was not declared in the ingredient statement, making the product adulterated and misbranded. * **U