Bake’N Joy Foods, Inc.

WARNING LETTER Bake’N Joy Foods, Inc. MARCS-CMS 608975 — October 29, 2020 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA UNITED PARCEL SERVICE Product: Food & Beverages Recipient: Recipient Name Mr. Robert M. Ogan Recipient Title President and CEO Bake’N Joy Foods, Inc. 351 Willow Street North Andover , MA 01845 United States Issuing Office: Division of Human and Animal Food Operations East I United States WARNING LETTER CMS # 608975 October 29, 2020 Dear Mr. Ogan: The United States Food and Drug Administration (FDA) has determined that you did not follow the requirements of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule) (21 CFR Part 117). The failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (located in subparts A, C, D, E, F, and G of part 117) is prohibited by section 301(uu) of the Act (21 U.S.C. § 331(uu)). You may find the Act and further information about the CGMP & PC rule through links in FDA's home page at http://www.fda.gov. On May 19, 2020, your firm recalled Sienna brand Cranberry Orange Flavored Muffin Batter after being notified by your customer that the product contained walnut pieces. The Cranberry Orange Flavored Muffin Batter is not formulated to contain walnuts, and walnuts are not declared on the product label. During production of the recalled product, a batch of cranberry nut batter, which contains walnuts, was added into the hopper of the depositor with cranberry orange batter. In documentation included with your May 22, 2020, email to the Office of Human and Animal Food Operations East Division 1 Recall Coordinator, you indicated that this occurred when a “batch of a nut-containing product was ‘dropped’ on top of the end of a non-nut containing product.” Also, in the documentation included in your email you stated that you have implemented corrective actions and provided a summary of the changes, which include re-training of operators and supervisors on procedures for “dropping” batches. Additionally, you performed a voluntary destruction of returned and on-hand recalled product. We will verify implementation of any corrective actions during FDA’s next inspection of your facility. Preventive Controls You did not identify and implement preventive controls to provide assurances that any hazard 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, as required by 21 CFR 117.135(a)(1) and (c)(2). Specifically, you did not identify and implement food allergen controls at the mixing/depositor step adequate to significantly minimize or prevent the hazard of undeclared allergens from cross-contact as evidenced by your firm’s adding cranberry nut batter to your Cranberry Orange Flavored Muffin Batter. This letter is not intended to be an all-inclusive list of violations at your facility or in connection with your products. You are responsible for ensuring that your facility operates in compliance with the Act, the CGMP & PC rule, and other applicable laws. You should take prompt action to correct the violations noted in this letter. Failure to do so may result in regulatory action by the FDA without further notice, including, without limitation, seizure and injunction. We will verify implementation of any corrective actions during FDA’s next inspection of your facility. If you would like to provide further details pertaining to the corrective actions taken by your firm and provide documentation, including revised procedures and completed monitoring records that would assist us in evaluating your corrections, please notify this office in writing within fifteen (15) working days of the receipt of this letter. If you believe that your products are not in violation of the Act or that you have complied with FDA regulations, include your reasoning and any supporting information for our consideration. If the corrective action cannot be completed within fifteen working days, state the reason for the delay and the time frame within which the corrections will be implemented. Your written response should be directed to the Food and Drug Administration, attention to: Mr. Scott Izyk, Compliance Officer, One Winners Circle, Suite 110, Albany, NY 12205 or email at scott.izyk@fda.hhs.gov. If you have questions regarding this letter, please contact Mr. Izyk at 518-453-2314 x1012 . Sincerely, /S/ Ronald Pace Program Division Director Office of Human and Animal Food Operations East Division 1 Content current as of: 11/03/2020 Regulated Product(s) Food & Beverages