FDA EIR - Kreyers Candy and Supplies LLC - August 31, 2020

A contract inspection of Kreyers Candy and Supplies LLC was conducted by the Wisconsin Department of Agriculture, Trade and Consumer Protection (WDATCP) on behalf of the FDA on August 31, 2020. This routine inspection, governed by the regulatory framework of 21 CFR Part 117 (Current Good Manufacturing Practice), focused on the firm's warehouse facility, which stores a variety of food products, single-use merchandise, and cleaning supplies. The inspection report indicated that no critical or non-critical violations were identified during this specific visit. However, an observation was made concerning the facility's pest control measures, noting that overhead doors and a side entrance were not completely sealed, which could potentially allow pest entry. A prior inspection on October 9, 2019, had identified a storage practice issue where products were stored directly on the floor in a walk-in freezer; this deficiency was documented as corrected. For the current inspection, the recommended follow-up was classified as "Routine/No Action Indicated." The company was provided with informational fact sheets on several Food Safety Modernization Act (FSMA) final rules and reminded of the ongoing requirement to register with the FDA every two years.