Additionally, in the longer-term, you will replace these high-pressure hoses with ones that are high flow/low pressure, and you will re-train your employees on how to properly use this piece of equipment. This swab site was in the same location as a previous, positive sample collected by FDA during our 2017 inspection. Friendly's has been a favorite family restaurant and ice cream purveyor for over 80 years! Specifically:”, “Your sanitation control procedure, “SSOP1 Cleanliness of Food Contact Surfaces,” states that “all food contact surfaces shall be cleaned and sanitized daily or as used.” However, the following practices were observed:”, “Cake molds had food debris (white and chocolate ice cream) from previous use when exiting the dishwasher. 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. Everything you love about birthday cake, whipped up into a Friend-z ® with Friendly's premium ice cream. The Food and Drug Administration sent a warning letter dated Nov. 22, 2019, to the president and CEO, Eric Beringause. Serve the cake straight from the freezer, unmould from the tin and pulling the clingfilm/clingwrap gently away before putting on a plate or cake stand. Browse our suite of goods in Ice Cream Cakes! We strongly encourage you to reassess and implement programs that are effective.”, “Your firm’s corrective action responses include actions your firm will take to address these findings, which include outlining specific uses for your green and orange pails and having a schedule to clean and sanitize your pails which will be monitored in your daily production records. Adulterated Animal Food – Unapproved Food Additive, “On February 11 and 12, 2019, during a complaint investigation, FDA collected for vitamin D analysis two samples of your Hills Prescription Diet Digestive Care i/d Low Fat (SKU Number 10423) canned dog food. “Employees were observed using high pressure hoses during the, “Employees were frequently observed handling hoses to wash down spills and excess food debris from the floors on, during ongoing production activities which resulted in overspray from the floors onto RTE chocolate fudge fillers and RTE fruit feeders containing nuts.”, “Our investigators observed the following practices involving pails and brushes which do not protect against contamination of food, food-contact surfaces, and food-packaging materials”, “Green pails designated for finished products/ingredients were used to hold overflow ice cream during production and were placed directly below pipes from which condensate dripped into them. Shop Meijer for Ice Cream Cakes at great low prices today! Under section 409 of the Act (21 U.S.C. Scrape the ice cream mixture into the springform tin flattening the top like a cake, and cover the top with clingfilm/clingwrap and place in the freezer to firm up. Once L. monocytogenes is established in a production area, personnel or equipment can facilitate the pathogen’s movement and contamination of food-contact surfaces and finished product. Get to know us! Friendly's; Menu; Specials; Join The Club; Locate; Order; Sign In × Friend-z ® Birthday Cake. Your 2017 environmental monitoring findings were discussed with your firm during our 2018 Regulatory Meeting.”, “You committed to performing corrective actions in written responses dated August 15, 2019, and September 11, 2019. Condensate was also observed dripping continuously from overhead manifold pipes on, onto floors below where it pooled, and these areas were observed with high foot traffic and pallet traffic. The Food and Drug Administration sent a warning letter dated Nov. 20, to the president and CEO of Hill’s Pet Nutrition, Peter Brons-Poulsen. Additionally, your firm’s environmental testing results for swabs collected in the, spp. Some letters are not posted for public view until weeks or months after they are sent. 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, 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. Mango. 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 second L. innocua swab was collected from a floor drain in the (redacted) area. In your response to the Form FDA 483, you stated that your food safety plan was not intended to cover “misformulation” by your supplier. ),” according to the warning letter. The adverse health consequences from consuming excessive levels of vitamin D can lead to kidney failure and even death.”. Making the world Friendly one scoop at a time. Specifically, were observed with continuously dripping condensate from overhead pipes collected over the single filler heads while filling containers with RTE ice cream. Friendly’s Manufacturing and Retail LLC — Wilbraham, MA All rights reserved. “These findings demonstrate that your sanitation procedures have been inadequate to significantly minimize or prevent, is established in a production area, personnel or equipment can facilitate the pathogen’s movement and contamination of food-contact surfaces and finished product.
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