FDA 483 - Jeni's Splendid Ice Creams, LLC - April 30, 2015

An FDA inspection of a facility manufacturing frozen ready-to-eat ice cream, yogurt, and sorbet revealed multiple violations of current good manufacturing practices.

Key issues include: - **Personnel Competency and Responsibility:** The Regulatory Manager and Director of Operations demonstrated a lack of competency by failing to institute environmental sampling/testing, being unaware of inadequate sanitation of batch freezers and sanitizing wipes, not knowing the need for floor sanitization, and permitting uncontrolled gardening by employees. - **Microbial Testing:** No environmental monitoring or finished product testing program was in place, despite manufacturing ready-to-eat products. - **Facility Space and Layout:** Insufficient space in prep and production rooms led to employee and equipment traffic congestion, and poor placement of sinks relative to open product. - **Sanitation and Maintenance:** Floors were not sanitized, spilled product was observed, and there were no door foamers to prevent cross-contamination. Dark residue was found on power outlets, light covers, and air returns. Dust and dirt were on fire sprinklers and hose reels. Discolored plastic strip curtains were noted. - **Equipment Design and Cleanliness:** Non-food-contact equipment (piston filler insulation) was not easily cleanable, with product leaks and residue. Batch freezers had unsealed holes and uncovered knob stems with adhering material, hindering proper cleaning. - **Raw Material Storage:** Ingredients like cocoa powder, sugar, and flour were stored directly beneath sinks used for washing raw