FDA WARNING_LETTER - Cracker King Corp. - June 20, 2017

On September 15, 2017, the FDA issued a Warning Letter to Cracker King Corp. following an inspection of their cracker manufacturing facility in Hempstead, NY, from June 7-20, 2017. The inspection revealed serious violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110), rendering their food products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations included: 1. **Lack of Allergen Control Program (21 CFR 110.80(b)(13)):** No program for products containing egg and soy, including production scheduling, dedicated equipment, or effective cleaning. 2. **Inadequate Cleaning of Food-Contact Surfaces (21 CFR 110.35(d)):** Food debris and dust observed on automated packaging line surfaces even after cleaning. 3. **Improper Equipment Design and Maintenance (21 CFR 110.40(a)):** Accumulation of debris on rough/pitted mixer blades, soiled/frayed brushes, pitted wooden tables, frayed/damaged conveyor belts, damaged rotary cutter bristles, non-cleanable sponge material in molds, carbon buildup/cracks on metal sheet pans, and chipped/peeling engineered wood in transport bins. Cardboard, a non-cleanable material, was