FDA WARNING_LETTER - Friendly's Manufacturing and Retail LLC - August 20, 2019

The FDA inspected Dean Foods' Friendly’s Manufacturing and Retail LLC facility in Wilbraham, MA, from July 29 to August 20, 2019, finding serious violations of the CGMP & PC rule (21 CFR Part 117). The facility manufactures ready-to-eat (RTE) ice cream products, syrups, and fudge.

Environmental swabs revealed *Listeria monocytogenes* (L. monocytogenes), matching a strain found in a 2017 inspection, indicating a resident pathogen. This renders the RTE food adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. The facility also failed to implement adequate preventive controls, violating section 301(uu) of the Act.

Specific violations include: - **Hazard Analysis and Risk-Based Preventive Controls (Subpart C):** Inadequate sanitation procedures to control *L. monocytogenes*, evidenced by repeated positive environmental swabs for *Listeria spp.* (13.4% in 2019, 20.9% in 2018, 16.4% in 2017). - **Current Good Manufacturing Practice (Subpart B):** - Failure to ensure proper hygienic practices by employees (e.g., not washing/changing gloves after touching non-food contact surfaces, licking bare hands after touching