The audit must be conducted before using the raw material or other ingredient from the supplier and at least annually thereafter (21 CFR 117.430(b)(1)(ii)). They were sold in espresso or cherry colors. Although you reanalyzed your food safety plan, your hazard analysis, dated April 13, 2019, still does not consider food allergens (i.e., the unintentional presence of milk) as a hazard for the receiving step of your bittersweet, (b)(4) chocolate ingredients. Makes 5 cups; approx 6-servings.
SIGNATURE REQUIRED In reply, refer to WL CMS 573446 Pamela Montgomery, President. Product recall: George Boys Dressing Gowns. The recalled berries were distributed to all Kroger branded stores throughout the U.S. Kroger has removed the contaminated berries from its store shelves, and has notified consumers that may have purchased the recalled berries through register receipt tape messages and phone calls. Specifically, you received results from the third-party laboratory indicating the presence of milk protein in the finished product and raw ingredients on September 14, 2018, and September 19, 2018. You also received FDA test results of the chocolate that you obtained from your supplier indicating milk protein levels as high as 4300 ppm. COMPANY ANNOUNCEMENT. The .gov means it’s official.Federal government websites often end in .gov or .mil. Call CPSC’s Hotline at 800-638-2772 (TTY 301-595-7054). Realspace® Magellan Performance Electric Height-Adjustable Desks, Bed Bath & Beyond Recalls SALT Lounge Chairs Due to Fall Hazard, Crate and Barrel Recalls Danish Tall Bookcases Due to Risk of Collapse; Injury Hazard to Consumers, CB2 Recalls Bordo Dining Tables Due to Injury Hazard, Harbor Breeze Kingsbury Ceiling Fans Recalled by HKC-US Due to Impact and Laceration Injury Hazards; Sold Exclusively at Lowe’s Stores, Caravan Global Recalls Chairs Due to Fall and Injury Hazards; Sold Exclusively at H-E-B Stores, View CPSC contacts for specific areas of expertise, 4330 East West Highway Bethesda, MD 20814. Withdrawals, & The need to consider milk allergens as a hazard requiring a supply-chain-applied control was highlighted by your supplier’s allergen policy indicating the possible presence of undeclared milk allergens. Your responses are addressed below. It is not clear whether these audits address whether the suppliers are in compliance with any applicable FDA food safety regulations and include a review of the supplier's written plan (e.g., Hazard Analysis and Critical Control Point (HACCP) plan or other food safety plan), if any, and its implementation, for the hazard being controlled, as required by 21 CFR 117.435(b). The U.S. Food and Drug Administration (FDA) inspected your chocolate confection production facility, located at 320 Wine Country Road, Prosser, Washington, from November 5, 2018, through November 28, 2018. Chukar Cherry Company. Your firm’s records for production on July 30, 2018, and on August 6, 2018, indicate your firm produced a milk-containing product, Cabernet Cherries, and subsequently manufactured a non-milk containing product, Ultra Dark Chocolate Amaretto Rainiers, on the same equipment. You did not document the monitoring of preventive controls, as required by 21 CFR 117.145(c). Your responses are not adequate. The desk’s control box is located under the desk on the right side and controls the desk’s upward and downward movements.
You are required to identify and implement preventive controls to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented and the food manufactured, processed, packed, or held by your facility will not be adulterated under section 402 or misbranded under section 403(w) of the Act (21 U.S.C. Due to the extraordinary circumstances surrounding COVID-19, some of the remedies identified in recall press releases may not be available at this time. Section 743 of the Act, (21 U.S.C. The .gov means it’s official.Federal government websites often end in .gov or .mil. Berry Recall 2019: Kroger, Costco Recall Frozen Berries For Hepatitis A Contamination Two recalls have been issued for frozen berries for a possible Hepatitis A contamination. SKU 358370 SKU 216230 “Espresso” “Cherry”. Your previous program required, monitoring. However, your Equipment Cleaning records do not indicate that a scrape, wash, dry, or inspection occurred between the two products. Accordingly, FDA may assess fees to cover any re- inspection-related costs. The Allergen Preventive Controls section of your food safety plan dated September 12, 2018, states that you will monitor by visual inspection the effectiveness of your “allergen change over procedures,” which should result in “no residual allergenic material from previous production/handling” on equipment and the production line. Our investigators observed (b)(4) hoses fully submerged inside the tray washing tank containing trays, water, and sanitizer. John T. Montgomery, Chief Financial Officer. The recall affects 4-pound bags of Kirkland Signature Three Berry Blend with a Best By Date between Feb. 16, 2020, and May 4, 2020. Questions about the recall can be directed to Townsend Farms’ customer service representatives at 1-877-244-0947 or by email at TownsendFarms4283@stericycle.com. By Vanessa Doctor 01/30/19 AT 4:40 AM. this link is to an external site that may or may not meet accessibility guidelines. Your December response states that you have retrained employees on hand washing procedures. Further, FDA found elevated levels of milk protein in the chocolate ingredients you use to produce your dark chocolate covered nut and fruit products. You did not determine and conduct appropriate supplier verification activities, as required by 21 CFR 117.415(a)(2). of sausages. The recalled berries should be disposed of. A re-inspection is one or more inspections conducted subsequent to an inspection that identified non-compliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. On November 7, 2018, our investigators observed the manufacturing of a nut-containing product (Cocoa Pecans) and the cleaning steps, which included an employee scraping the remainder of the chocolate from the pan and scrubbing the pan with hot water and a scrub brush. In an official news release dated Jan. 24, the agency said that the withdrawal involves fruit by the brand Rio Duero and listing Chile as their country of origin. These vents are used to blow air over all varieties of chocolates including milk, tree nut, and non-milk, non-tree nut products, which could cause cross contact of milk and tree nuts in products that do not contain milk and tree nut ingredients during the (b)(4) process. We have reviewed your written responses and determined they are not adequate. Office Depot stores in the United States and Puerto Rico and online at officedepot.com from April 1, 2017 through February 22, 2019 for about $500. Specifically, your revised cleaning records for “Choc Room Pans” do not indicate that a “scrape” was consistently performed on the pans as required by your cleaning procedure between changeovers.
The desks have the Office Depot SKU number 358370 (espresso) or 216230 (cherry) printed on a label located underneath the desk top. You did not determine and conduct appropriate supplier verification activities, as required by 21 CFR 117.415(a)(2).
En Español. The timing and frequency for collecting and testing samples must be adequate to determine whether preventive controls are effective, as required by 21 CFR 117.165(b)(3)(iv). However, you did not implement an environmental monitoring program. Congressional and Public Affairs Felicia Thompson (202) 720-9113 Press@fsis.usda.gov . Phone: (301) 504-7908 While your response provides documentation that you have trained your employees, it is not clear what steps you will take to ensure this training was effective and to ensure these violations do not recur. If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration. While your response provides documentation that you have trained your employees, it is not clear what steps you will take to ensure this training was effective and to ensure these violations do not recur.
You identified the food safety hazards of Salmonella and E. coli in your hazard analysis with regard to (b)(4). b. 7. Your December response states. of sausages that may have been contaminated with plastic material. At some point he started working at least part time from home. On November 7, 2018, our investigators observed apparent chocolate powder and residue on the outside and inside of the air vents for pan #(b)(4) and #(b)(4). Customers who have purchased the above products should not consume them and should return them to a store for a full refund or replacement. monitoring would not be sufficient for your manufacturing operations. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Kroger was informed by the FDA that a sample of the Private Selection frozen berries was tested by the FDA and found to be contaminated with Hepatitis A. Kroger is recalling the following items, which were distributed to all Kroger family of store banners across the country: Kroger has removed the potentially affected items from store shelves and initiated its customer recall notification system that alerts customers who may have purchased recalled products through register receipt tape messages and phone calls. Based on FDA’s findings during the inspection we have determined that your dark chocolate covered nut and fruit products are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act [21 United States Code § 342(a)(4)] (the Act), in that they were prepared, packed or held under insanitary conditions whereby they may have been contaminated with filth or rendered injurious to health. Sort By. They should be returned to the place of purchase for a full refund or replacement. Your December response states that you have updated cleaning procedures and retrained employees. Before sharing sensitive information, make sure you're on a federal government site. You'll get the latest updates on this topic in your browser notifications. Two recalls have been issued for frozen berries for a possible Hepatitis A contamination. You identified the food safety hazards of, 5. Hepatitis A is a contagious liver disease that results from exposure to the Hepatitis A virus, including from food. Grid; List; October 20, 2020. 20th October 2020 1 Min Read. FDA does not endorse either the product or the company. More Recalls, Market The company has not received any reports of illness from the recalled berries. We reviewed your responses and determined that this violation was not corrected. Safety Alerts, An official website of the United States government, : Your previous program required (b)(4) monitoring.
Your hazard analysis did not identify the unintentional presence of milk allergens as a hazard requiring a supply-chain applied control in the bittersweet, (b)(4) chocolate you obtain and therefore is a hazard that requires that you have a supply-chain control, as required by 21 CFR 117.130(a)(1) and 21 CFR 117.405(a)(1). The products were distributed by Jac. The Kroger products were distributed to all Kroger and Kroger-affiliate stores across the country, including Ralphs, Fry’s and Fred Meyer. In your April response you provided test results for pecan and almond residue in your reworked chocolate. This recall involves Realspace Magellan Performance-Electric Height-Adjustable Desks. However, the food allergen controls you have in place do not ensure protection of food from allergen cross-contact, including during storage, handling and use, as required by 21 CFR 117.135(c)(2)(i).