For example, your requirement for vitamin premixes with vitamin D to have a COA, was documented in your ingredient specification before the recall. Specifically, you did not appropriately evaluate environmental pathogens as required by 21 CFR part 117.130(c)(ii). You must, though, serve a warm sauce with it - it's the crowning glory - and I've certainly given you options below. As a result of your failure to consistently implement your pre-requisite program, a systematic failure of your food safety plan occurred that resulted in the recall of canned dog food as identified above. Although vitamin D is an essential nutrient that allows dogs to regulate the balance and retention of calcium and phosphorus, when high levels of vitamin D are consumed, excessive amounts are not excreted but are stored in fat tissue and the liver. Testing of the products revealed the following results:”, “A food additive is a substance that becomes a component of food unless it is generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures to be safe under the conditions of its intended use.5 According to scientific literature reviewed and summarized by scientific committees in the National Research Council, and the 2017 Official Publication of the Association of American Feed Control Officials on pages 149-162, vitamin D in dog food is safe in the amount of 500 to 3,000 IU/kg.7 According to the scientific literature, concentrations of vitamin D in dog food above 4,000 IU/kg dry matter cause signs of vitamin D toxicosis, with severity of signs increasing with increasing concentrations of the vitamin.7 Although vitamin D is an essential nutrient that allows dogs to regulate the balance and retention of calcium and phosphorus, when high levels of vitamin D are consumed, excessive amounts are not excreted but are stored in fat tissue and the liver. (redacted) and noted that “[n]utrient deficiency or toxicity hazards can be the result of incorrect levels of nutrients in incoming raw materials or ingredients.””, “Your response states that your firm is now implementing a process preventive control at the (redacted) step; however, you did not provide adequate documentation demonstrating the implementation and effectiveness of the preventive control to include the associated management components as required by 21 CFR 507.39 and therefore we are unable to determine the adequacy of this corrective action.”, “The corrective action of a “process preventive control” at your (redacted) step (redacted). The adverse health consequences from consuming excessive levels of vitamin D can lead to kidney failure and even death.”, “The above-referenced dog food samples contained vitamin D at levels in excess of 33 times the recommended safe upper limit. Friendly's. These violations render your animal food products adulterated under the FD&C Act. As evidenced by environmental findings that indicate a resident strain of, in your facility, environmental pathogens are a hazard in your facility; your sanitation controls (i.e., your SSOPs) are not adequate to ensure that your facility is maintained in a sanitary condition to significantly minimize or prevent the hazard of the environmental pathogen, , as required by 21 CFR §§ 117.135(a)(1) and (c)(3).”, “You did not take reasonable measures and precautions to ensure all persons working in direct contact with food, food-contact surfaces, and food-packaging materials conform to hygienic practices while on duty to the extent necessary to protect against contamination of food, as required by 21 CFR § 117.10(b). Making the world Friendly one scoop at a time. In response to these deviations, the FDA issued an FDA 483, Inspectional Observations that lists deviations observed at the facility. 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. As a result, you used vitamin premix containing a concentration of vitamin D that was outside your specification.”, “We acknowledge your promised corrective actions in your written responses dated March 12, 2019, May 23, 2019, and August 30, 2019 to the Form FDA 483, which include implementing a, Certificate of Analysis (COA) requirement for vitamin premixes and trace mineral premixes, revising the Receiving Procedure to address the need for, , training personnel on the revised Receiving Procedure, integrating COA requirements into an internal system so that incoming vitamin and trace mineral premix ingredients cannot be received without conforming COAs, conducting an onsite audit of your supplier’s facility, revising your Food Safety Plan, and implementing a process preventive control for the, steps to enhance control of the misformulation hazard.”, “We are unable to assess the adequacy of your corrective actions because many are preexisting procedures that were not followed consistently prior to the recall event. Bakery. Your firm’s corrective action response received on September 11, 2019, addresses the immediate concerns as well as outlines long term corrective actions that you plan on implementing, including re-training your employees on the usage of gloves and updating your RTE Brill handling process to address this observation. positive swabs. But you can make irresitable rich and creamy Mango ice cream with it, which is what we did. § 348), a food additive is unsafe unless a regulation is in effect that prescribes the conditions under which the additive may be safely used, and the additive and its use or intended use are in conformity with that regulation. In addition, employees were observed using yellow brushes designated for “exterior surfaces,” such as wheels and floors, to scrub areas around food contact surfaces such as conveyor belts, scales, work tables.”, “You did not conduct operations under conditions and controls necessary to minimize the potential for contamination of food, as required by 21 CFR § 117.80(c)(2). The FDA says they received a written response dated Mar. 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. This was further confirmed by your firm’s special instructions to your supplier. Condensate continuously dripped from overhead pipes and collected on a plexiglass shield placed above the assembly line on, . Let the ice cream soften either in the refrigerator for a while, or out in the kitchen. Based on FDA’s inspectional findings and the analytical results for the environmental samples, we determined that the RTE food manufactured in your facility is adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. It is essential to identify the areas of the food processing plant where this organism is able to survive and grow to take such corrective actions as necessary to eradicate the organism by rendering these areas unable to support the survival and growth of the organism and prevent the organism from being re-established in such sites.”, “Additionally, during FDA’s 2019 inspection, two environmental swabs were positive for, swabs was collected from ice cream dripping from a valve on a freezer cycle in, where Friendly’s brand strawberry shortcake sundaes were being manufactured. Current Good Manufacturing Practice (Subpart B): “These types of practices are a repeat observation from our 2017 inspection. Vanilla Pineapple. This swab site was in the same location as a previous L. monocytogenes positive sample collected by FDA during our 2017 inspection. Everything you love about birthday cake, whipped up into a Friend-z(R) with Friendly's premium ice cream. We will verify the implementation and adequacy of these corrective actions during our next inspection.”. At these levels, vitamin D is not generally recognized as safe; therefore, it is a food additive. FDA laboratory analyses of the environmental swabs found the presence of. We recommend that you continue to implement these corrective actions to ensure that L. monocytogenes does not contaminate your RTE food products.