FDA WARNING_LETTER - K. Heeps, Inc - August 29, 2011

On September 23, 2011, the FDA issued a Warning Letter to K. Heeps, Inc. following an inspection from August 17-29, 2011, at their Allentown, PA facility. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR 123) and Current Good Manufacturing Practice (21 CFR 110).

The FDA determined that several products, including "Not Fully Cooked Not Shelf Stable - Frozen Fish Puree," fresh/frozen "broiled or flash fried crab cakes," "flash fried flounder," "parmesan crusted tilapia," "jumbo coconut shrimp," "jumbo shrimp," "lobster mashed potatoes," and "flash fried crab cake nugget," were adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act due to insanitary conditions.

Key violations included: 1. **Lack of HACCP Plans:** The firm lacked HACCP plans for multiple products (e.g., crab cakes, flounder, tilapia, shrimp, lobster mashed potatoes) to control undeclared food allergens (wheat, soy, milk, crustaceans, fish) on finished product labels, violating 21 CFR 123.6(a) and (b). 2. **Inadequate HACCP Plan for "Fish Puree":** *