FDA WARNING_LETTER - E R K Distributors LLC. - October 02, 2013

On October 28, 2013, the FDA issued a Warning Letter to ERK Distributors, LLC, following an inspection from September 24 to October 2, 2013. The inspection revealed serious violations of the Seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), rendering their Shrimp Egg Rolls, Shrimp & Pork Egg Rolls, and Seafood & Cream Cheese Calzones adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Lack of Hazard Analysis and HACCP Plan:** The firm failed to conduct a hazard analysis or implement a written HACCP plan for Shrimp Egg Rolls, Shrimp & Pork Egg Rolls, Seafood & Cream Cheese Pierogi, and Seafood & Cream Cheese Mini Calzones, as required by 21 CFR 123.6(a), (b), and (c)(1). 2. **Inadequate Sanitation Monitoring:** The firm failed to adequately monitor sanitation conditions (21 CFR 123.11(b)), specifically regarding cross-contamination prevention, hand washing facilities, and protection of food/food contact surfaces. Examples included: * Cross-contamination of allergens (shrimp) due to lack of cleaning between product runs. * Empty soap dispensers at hand washing stations. * Uncleaned utensils and fryer