FDA WARNING_LETTER - Crispy Delight Corp. - April 25, 2019

The FDA inspected Nice & Fresh Inc.'s RTE baked goods facility from April 9-25, 2019, revealing serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (21 CFR 117). The inspection found products adulterated under 21 U.S.C. § 342(a)(4) due to insanitary conditions. Key deficiencies included the absence of a written food safety plan, inadequate hazard analysis, and insufficient preventive controls for allergens and process validation. The facility exhibited extensive pest activity, including live rodents and cockroaches, and rodent excreta, violating 21 CFR 117.35(c). Quality control for packaging was deficient, with contaminated, reused cardboard boxes. The firm failed to minimize microbial growth and allergen cross-contact, with filth on equipment, condensate dripping onto products, and uncleaned ingredient bags. Equipment was in disrepair, and sanitary facilities were inadequate, lacking handwashing stations and proper hand drying. Additionally, Cake Donut and Yeast Donut products were adulterated for containing undeclared FD&C Yellow No.5. All products were misbranded under 21 U.S.C. § 343 for failing to declare major food allergens correctly, missing ingredient statements, common names, color additive declarations, place of business, and net quantity of contents. The facility's food facility registration was also canceled. The firm provided responses outlining corrective actions, which FDA will verify during a future inspection. Failure to correct violations may lead to regulatory action, including seizure, injunction, or registration suspension, and re-inspection fees.