. . Friendly's. This location is adjacent to a drain where, in 2017, FDA isolated L. monocytogenes and L. innocua. “One environmental swab collected from the floor area of (redacted) during FDA’s 2019 inspection contained L. monocytogenes. Get in that vacation state of mind when you enjoy our super premium vanilla ice cream with juicy pineapple pieces. ; and from January 2017 through July 2017, 16.4% of all swabs taken were positive for Listeria spp. Specifically, from January 2019 through July 2019, 13.4% of all swabs taken were positive for, . This was further confirmed by your firm’s special instructions to your supplier. In your written responses, you indicate that you have taken a number of corrective actions, which include performing an intensified cleaning and sanitizing of your production area; conducting a root cause analysis in response to our environmental findings; shutting down (redacted) to perform targeted remediation work, clean and sanitize, and conduct verification swabbing; conducting a refresher training for employees; and performing intensified cleaning of all utensils, work surfaces, and equipment. Specifically, your sanitation control procedure, “PP3 Current Good Manufacturing Practices,”, products or product contact surfaces. “During our inspection of your facility, FDA Investigators noted violations of the Hazard Analysis and Risk- Based Preventive Controls requirements for animal food found in Title 21 of the Code of Federal Regulations, part 507, subpart C (21 CFR part 507, subpart C). positive swabs. Your firm’s corrective action responses received on August 15, 2019 and September 11, 2019, address the immediate sanitation concerns as well as outline long term corrective actions that you plan on implementing, including consulting with a third-party expert to assist in assessing how to implement better condensate control within your environment and implementing corrective action measures based on your findings. All rights reserved. The Food and Drug Administration sent a warning letter dated Nov. 22, 2019, to the president and CEO, Eric Beringause. A complete list of the violations can be found in the FDA’s warning letter. Your ingredient specification for the vitamin premix included a target specification for vitamin D and states that the “Supplier must include Certificate of Analysis, ,” but your firm did not obtain Certificates of Analysis (COA) upon receipt, of vitamin premix from your supplier. Friendly’s changed the dessert game last year when it unveiled its Cake Singles, which let you dive into a personal-sized ice cream cake.While some days we would like to eat an entire ice cream cake by ourselves, it’s probably good that we have the smaller option. The FDA says they received a written response dated Aug. 15, 2019, describing corrective actions taken and planned by the firm. Order Now. We will verify the adequacy of these corrective actions during our next inspection.”, “You did not clean your non-food contact surfaces in a manner and as frequently as necessary to protect against contamination of food, food-contact surfaces, and food-packaging materials, as required by 21 CFR § 117.35(e). Further, your firm’s environmental testing results from May 1, 2018, to July 5, 2019, for swabs collected from the WC4 area show several Listeria spp. The presence of the same strain. This was further confirmed by your firm’s special instructions to your supplier (redacted). Under section 409 of the Act (21 U.S.C. Milk, Cream, Skim Milk, Sugar, Corn Syrup, Mango Puree, Whey Protein Concentrate, Whey, Buttermilk, Annatto Extract And Turmeric (Color), Guar Gum, Natural Flavor, Beet Juice (Color), Mono And Diglycerides, Xanthan Gum, Carrageenan. Your firm also failed to test, evaluate against your specification, and subsequently reject the vitamin premix containing excess vitamin D, as required by your food safety plan. . We will verify the adequacy of these corrective actions during our next inspection.”, “Your firm’s corrective action responses include actions your firm will take to address these findings which include using (redacted) towels only throughout the plant for equipment, pipes, and other non-food contact surfaces; updating your written programs, SSOP 1 Cleanliness of Food Contact Surfaces and Current GMPs-PC-7; and identifying your sanitation hose (redacted). The FDA says they received a written response dated Mar. We observed, cloths being used in various activities during production, including wiping down condensate, conveyors, scales, and RTE cake decorating stands; covering food; and wiping off excess food from the sides of cake molds. Additionally, your firm’s environmental testing results for swabs collected in the, spp. These pails were also observed being emptied into a discarded product vat during which the rim and exterior of the pails came into contact with the discarded food and the food vat and then returned to the production line without any cleaning or sanitizing.”, “Employees were observed moving orange pails to multiple surfaces within the production environment without cleaning or sanitizing the pails between uses.