Canyon Farms, Inc.

WARNING LETTER Canyon Farms, Inc. MARCS-CMS 608288 — July 16, 2020 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: United Parcel Service Product: Food & Beverages Recipient: Recipient Name Ms. Michelle Yu Recipient Title Owner Canyon Farms, Inc. 8033 W Sunset Blvd, Suite 949 Los Angeles , CA 90046-2401 United States Issuing Office: Division of West Coast Imports United States WARNING LETTER July 16, 2020 Re: CMS # 608288 Dear Ms. Yu: From April 17, 2020 through May 5, 2020, the Food and Drug Administration conducted a remote Foreign Supplier Verification Program (FSVP) inspection for Canyon Farms, Inc., located at 8033 W Sunset Blvd, Suite 949, Los Angeles, CA 90046-2401. We also conducted an inspection on March 26, 2019. These inspections were conducted to determine compliance with the requirements of section 805 of the Federal Food, Drug and Cosmetic Act (FD&C Act) (21 U.S.C. 384a) and the Foreign Supplier Verification Program (FSVP) implementing regulation in 21 CFR part 1 subpart L. The FSVP regulation requires that importers perform certain risk-based activities to verify that human and/or animal food they import into the United States has been produced in a manner that meets applicable U.S. food safety standards. You may find information relating to the FSVP regulation and your responsibilities to comply with the regulation through links in FDA’s FSVP web page at https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm361902.htm During the most recent inspection, we found that you are not in compliance with the requirements of 21 CFR part 1 subpart L for the food products you import including, but not limited to, Sweet Pickle Relish imported from (b)(4) ; Whole Dill Pickles imported from (b)(4) , both located in (b)(4) ; Nacho Sliced Jalapeno Peppers imported from (b)(4) ; and Minced Garlic imported from (b)(4) . Because of these significant violations, you are not in compliance with section 805 of the FD&C Act. At the conclusion of both the initial FSVP inspection and the follow-up inspection on May 5, 2020, our investigator provided you in each instance with a Form FDA 483a, FSVP Observations. We acknowledge receipt of your responses via email from Mr. Ethan Summers dated May 7, 2020 and June 24, 2020, in which you state you had hired a company, (b)(4) ., to help you with your plan and you were working to be in full compliance with FDA as soon as possible. You provided (b)(4) sets of FSVP documents in your June 24, 2020 email. The sets of documents each included a “FSVP Food Safety Plan,” signed as approved by you on May 15, 2020, which included product specifications, labeling, and process flowchart and narrative specific to your Sweet Pickle Relish, Whole Dill Pickles, and Nacho Sliced Jalapeno Peppers, as well as a Hazard Analysis and HACCP Plan for Pickled Vegetables pH (b)(4) . You also provided a certificate of analysis and lab test report dated July 25, 2019 for your Nacho Sliced Jalapenos and a Foreign Supplier Approval Survey form for (b)(4) , dated June 19, 2017. You did not provide any documents related to your Minced Garlic, or any product imported from (b)(4) , or (b)(4) . Our review of your response finds that you have not addressed all the violations related to the food products you import, as further described in this letter. Your significant violations of the FSVP regulation are as follows: 1. You did not meet the requirements to conduct a hazard analysis for the products you import in accordance with 21 CFR 1.504. Specifically, for your Whole Dill Pickles, imported from your foreign supplier (b)(4) , located in (b)(4) , and your Minced Garlic imported from your foreign supplier (b)(4) ., located in (b)(4) , you do not have a hazard analysis. For your Sweet Pickle Relish, Whole Dill Pickles, and Nacho Sliced Jalapeno Peppers imported from your foreign supplier (b)(4) , located in (b)(4) , while you have obtained a hazard analysis from your foreign supplier for each of these products, you did not document your review and assessment of your foreign supplier’s hazard analysis as required by 21 CFR 1.504(d). 2. You did not meet the requirements to evaluate your foreign supplier’s performance in accordance with 21 CFR 1.505 for the products you import. Specifically, for your Minced Garlic imported from your foreign supplier (b)(4) ., located in (b)(4) , you did not provide supplier evaluation information. For your Whole Dill Pickles, imported from your foreign supplier (b)(4) , located in (b)(4) , while you have obtained a “Foreign Supplier Approval Survey” from your supplier (b)(4) , you did not document your evaluation of this information in accordance with 21 CFR 1.505(a)(2) or your approval of this supplier in accordance with 21 CFR 1.505(b). For your Sweet Pickle Relish, Whole Dill Pickles, and Nacho Sliced Jalapeno Peppers imported from your foreign supplier (b)(4) , located in (b)(4) , while you have obtained a “Foreign Supplier Approval Survey” from your supplier (b)(4) , you did not document your evaluation of this information in accordance with 21 CFR 1.505(a)(2) or your approval of this supplier in accordance with 21 CFR 1.505(b). 3. You did not meet the requirements to perform foreign supplier verification activities in accordance with 21 CFR 1.506 for the products you import. Specifically, you did not document your determination or performance of appropriate supplier verification activities for the Whole Dill Pickles or Sweet Pickle Relish imported from your foreign supplier (b)(4) , located in (b)(4) , or for the Whole Dill Pickles, imported from your foreign supplier (b)(4) , located in (b)(4) . For your Minced Garlic imported from your foreign supplier (b)(4) ., located in (b)(4) , you obtained several audit certificates, but the certificates do not include audit procedures or refer to specific FDA regulations. For your Nacho Sliced Jalapeno Peppers imported from your foreign supplier (b)(4) , while you obtained a Certificate of Analysis and Lab Test Report, you did not establish written procedures for ensuring that appropriate supplier verification activities are conducted in accordance with 21 CFR 1.506(b) and you did not document your determination of the appropriate supplier verification activity in accordance with 21 CFR 1.506(d). The above violations are not intended to be an all-inclusive list of violations of the FSVP requirements. It is your responsibility to ensure that you are in compliance with section 805 of the FD&C Act and the implementing regulation in 21 CFR part 1 subpart L. You should take prompt action to correct the above violations. If you do not promptly correct them, we may take further action. For instance, we may take action under section 801(a)(3) of the FD&C Act (21 U.S.C. 381(a)(3)) to refuse admission of the food products you import. We may place the foods you import on detention without physical examination (DWPE) when you import the products. You can find DWPE information relating to FSVP in Import Alert # 99-41 at http://www.accessdata.fda.gov/cms_ia/ialist.html . In addition, the importation or offering for importation into the United States of an article of food without the importer having an FSVP that meets the requirements of section 805 of the FD&C Act or the FSVP regulation is prohibited under section 301(zz) of the FD&C Act. You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should address the specific things you are doing to correct these violations. You should include in your response documentation and information that would assist us in evaluating your corrections, (e.g., documentation of changes you made, such as a copy of your revised FSVP, records to demonstrate implementation of your FSVP, and any additional information that you wish to supply relevant to your compliance with the FSVP regulation). If you believe that you are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete all corrections within 15 days, you should explain the reason for your delay and state when you will correct any remaining violations. Please send your reply to Food and Drug Administration, Attention: Dennis N. Hoang, Compliance Officer, Division of West Coast Imports, One World Trade Center, Suite 300, Long Beach, CA 90831. If you have any questions regarding this letter, you may contact Compliance Officer Hoang via email at dennis.hoang@fda.hhs.gov. Please reference CMS #608288 on any documents or records you provide to us and/ or within the subject line of any email correspondence you send to us. Sincerely, /S/ Dan R. Solis Program Division Director Division of West Coast Imports One World Trade Center, Suite 300 Long Beach, CA 90831 Content current as of: 09/29/2020 Regulated Product(s) Food & Beverages