[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-jds-market-inc-616100-10152021":3,"fda-latest-sync-dates":29},{"id":4,"letter_id":5,"action_type":6,"firm_name":7,"fei_number":8,"issuing_office":9,"subject":10,"posted_date":11,"action_taken_date":12,"response_letter_date":8,"closeout_date":8,"case_status":13,"letter_url":14,"reference_number":8,"marcs_cms_no":15,"product_type":16,"delivery_method":17,"recipient_name":18,"recipient_title":8,"body_html":19,"body_text":20,"body_fetched_at":21,"medical_device_id":8,"raw":22,"created_at":27,"updated_at":28},3027,"jds-market-inc-616100-10152021","Warning Letter","JD's Market Inc.",null,"Division of West Coast Imports","Foreign Supplier Verification Program (FSVP)","2021-11-16","2021-10-15","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fjds-market-inc-616100-10152021","616100","Food & Beverages","United Parcel Service","Roobina Raja and Roobina Sardar","\n\n                            \n                            \n                            \n                            \n                                              \n  \n \n\n                 \n\n  \u003Chr>\n \n\n\u003Cdiv class=\"inset-column\">\n  \u003Cdl class=\"lcds-description-list--grid\">\n\n              \u003Cdt class=\"cell-1_1\">Delivery Method:\u003C\u002Fdt> \n        \u003Cdd class=\"cell-2_1\">United Parcel Service\n                                                                                                                                                                                                                                                                                                                                                                                                                              \u003C\u002Fdd>\n      \n      \n              \u003Cdt class=\"cell-1_3\">Product:\u003C\u002Fdt> \n        \u003Cdd class=\"cell-2_3\">Food & Beverages                          \n            \n            \n            \n            \n            \n            \n            \n             \n            \n            \n            \n              \n            \n            \n            \u003C\u002Fdd>\n      \n          \u003C\u002Fdl>\n  \u003C\u002Fdiv>            \n\n\n\u003Chr>\n\n\u003Cdiv class=\"row inset-column\">\n  \u003Cdiv class=\"col-xs-12 col-md-6\">\n    \u003Cdl class=\"\">\n\n        \u003Cdt>Recipient:\u003C\u002Fdt>\n\n                      \u003Cdd>\n  \u003Cdiv class=\"field field--name-field-recipient-name field--type-string field--label-above\">\n    \u003Cdiv class=\"field--label\">Recipient Name\u003C\u002Fdiv>\n              \u003Cdiv class=\"field--item\">Roobina Raja and Roobina Sardar\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n                                \u003Cdd>\n  \u003Cdiv class=\"field field--name-field-recipient-title field--type-string field--label-above\">\n    \u003Cdiv class=\"field--label\">Recipient Title\u003C\u002Fdiv>\n              \u003Cdiv class=\"field--item\">Co-Owners\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n          \n            \u003Cdd>JD's Market Inc.\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">4419 200th Street SW\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"locality\">Lynnwood\u003C\u002Fspan>, \u003Cspan class=\"administrative-area\">WA\u003C\u002Fspan> \u003Cspan class=\"postal-code\">98036-6601\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"country\">United States\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n          \n          \n          \n    \u003C\u002Fdl>\n  \u003C\u002Fdiv>            \n\n       \u003Cdiv class=\"col-xs-12 col-md-6\">\n    \u003Cdl class=\"\">\n          \n          \u003Cdt>Issuing Office:\u003C\u002Fdt>\n        \n         \n          \u003Cdd>Division of West Coast Imports\u003C\u002Fdd>\n        \n         \n          \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"country\">United States\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n        \n        \n        \n        \n        \n    \u003C\u002Fdl>\n    \u003Cdl class=\"\"> \n      \n    \u003C\u002Fdl>\n  \u003C\u002Fdiv>  \n      \n\u003C\u002Fdiv>\n\n \n\n \n\n\u003Chr>\n\n\u003Cp align=\"center\" style=\"text-align:center\">\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"font-family:Calibri,sans-serif\">\u003Cb>\u003Cspan style=\"font-size:12.0pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">WARNING LETTER\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fb>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"text-autospace:none\">\u003Cspan style=\"font-family:Calibri,sans-serif\">\u003Cspan style=\"font-size:12.0pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">October 15, 2021\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp class=\"text-align-center\">\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"font-family:Calibri,sans-serif\">\u003Cspan style=\"font-size:12.0pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"color:black\">Re:  CMS # \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:12.0pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">616100\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"font-family:Calibri,sans-serif\">\u003Cspan style=\"font-size:12.0pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">Dear Ms. Raja and Ms. Sardar: \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"text-autospace:none\">\u003Cspan style=\"font-family:Calibri,sans-serif\">\u003Cspan style=\"font-size:12.0pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">On May 3 and May 17-21, 2021, the Food and Drug Administration (FDA) conducted a remote Foreign Supplier Verification Program (FSVP) inspection of JD’s Market Inc., located at \u003Cspan style=\"color:black\">4419 200th Street SW Lynnwood, WA 98036-6601. \u003C\u002Fspan>We also conducted an inspection on \u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:12.0pt\">\u003Cspan style=\"font-family:TimesNewRomanPSMT\">March 1, 2019\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:12.0pt\">\u003Cspan style=\"font-family:TimesNewRomanPSMT\">. \u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:12.0pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">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 implementing FSVP regulation in 21 CFR part 1 subpart L.\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp style=\"text-align:justify\">\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"font-family:Calibri,sans-serif\">\u003Cspan style=\"font-size:12.0pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">The FSVP regulation requires that importers perform certain risk-based activities to verify that human and\u002For 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 \u003C\u002Fspan>\u003C\u002Fspan>\u003Ca href=\"https:\u002F\u002Fwww.fda.gov\u002Ffood\u002Ffood-safety-modernization-act-fsma\u002Ffsma-final-rule-foreign-supplier-verification-programs-fsvp-importers-food-humans-and-animals\" style=\"color:blue; text-decoration:underline\">\u003Cspan style=\"font-size:12.0pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">https:\u002F\u002Fwww.fda.gov\u002Ffood\u002Ffood-safety-modernization-act-fsma\u002Ffsma-final-rule-foreign-supplier-verification-programs-fsvp-importers-food-humans-and-animals\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fa>\u003Cspan style=\"font-size:12.0pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">.\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp style=\"text-align:justify\">\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:Calibri,sans-serif\">\u003Cspan style=\"color:black\">\u003Cspan style=\"font-family:"Times New Roman",serif\">During the most recent inspection, we found that you are\u003Ci> \u003C\u002Fi>not\u003Ci> \u003C\u002Fi>in compliance with the requirements of 21 CFR part 1 subpart L for the foods you import. Because of these significant violations, you are not in compliance with section 805 of the FD&C Act. \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp style=\"text-align:justify\">\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"font-family:Calibri,sans-serif\">\u003Cspan style=\"font-size:12.0pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">At the conclusion of the inspection, our investigator provided you with a Form FDA 483a, FSVP Observations. \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp style=\"text-align:justify\">\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"font-family:Calibri,sans-serif\">\u003Cspan style=\"font-size:12.0pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">We have not received your response to the Form FDA 483a issued on May 21, 2021.\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp style=\"text-align:justify\">\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"font-family:Calibri,sans-serif\">\u003Cspan style=\"font-size:12.0pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">Your significant violations of the FSVP regulation are as follows:\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp style=\"text-align:justify\">\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"font-family:Calibri,sans-serif\">\u003Cspan style=\"font-size:12.0pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">You did not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a). Specifically, you did not develop, maintain, and follow an FSVP for any of the foods you import, including the following foods:\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cul>\n\t\u003Cli style=\"margin-left:32px\">\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"font-family:Calibri,sans-serif\">\u003Cspan style=\"font-size:12.0pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"color:black\">Jumbo Raisins imported from \u003Cstrong>(b)(4)\u003C\u002Fstrong>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fli>\n\t\u003Cli style=\"margin-left:32px\">\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"font-family:Calibri,sans-serif\">\u003Cspan style=\"font-size:12.0pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">Dry Plums imported from \u003Cspan style=\"color:black\">\u003Cstrong>(b)(4)\u003C\u002Fstrong>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fli>\n\t\u003Cli style=\"margin-left:32px\">\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"font-family:Calibri,sans-serif\">\u003Cspan style=\"font-size:12.0pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">After Meal Snacks imported from \u003Cspan style=\"color:black\">\u003Cstrong>(b)(4)\u003C\u002Fstrong>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fli>\n\u003C\u002Ful>\n\n\u003Cp>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"text-autospace:none\">\u003Cspan style=\"font-family:Calibri,sans-serif\">\u003Cspan style=\"font-size:12.0pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">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. \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"font-family:Calibri,sans-serif\">\u003Cspan style=\"font-size:12.0pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">This letter notifies you of our concerns and provides you an opportunity to address them.  If you do not adequately address this matter, 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 you import for which you appear to be in violation of section 805. We may place the foods you import into the United States on detention without physical examination (DWPE) when you import the foods.  You can find DWPE information relating to FSVP in Import Alert #99-41 at \u003C\u002Fspan>\u003C\u002Fspan>\u003Ca href=\"http:\u002F\u002Fwww.accessdata.fda.gov\u002Fcms_ia\u002Fialist.html\" style=\"color:blue; text-decoration:underline\">\u003Cspan style=\"font-size:12.0pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"color:blue\">http:\u002F\u002Fwww.accessdata.fda.gov\u002Fcms_ia\u002Fialist.html\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fa>\u003Cu>\u003Cspan style=\"font-size:12.0pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"color:blue\">. \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fu>\u003Cspan style=\"font-size:12.0pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">In addition, t\u003Cspan style=\"background:white\">\u003Cspan style=\"color:black\">he 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 \u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"background:white\">\u003Cspan style=\"color:#212121\">(\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:12.0pt\">\u003Cspan style=\"background:white\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"color:#212121\">21 U.S.C. 331(zz))\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:12.0pt\">\u003Cspan style=\"background:white\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"color:black\">.\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"font-family:Calibri,sans-serif\">\u003Cspan style=\"font-size:12.0pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">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 any 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 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.\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp style=\"text-align:justify\">\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"font-family:Calibri,sans-serif\">\u003Cspan style=\"font-size:12.0pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">We note that you may meet the definition of a “very small importer” under 21 CFR 1.500.  If you meet the definition, you are still required to follow FSVP requirements.  If you are a very small importer and you choose to comply with the modified requirements in 21 CFR 1.512, you must document that you meet the definition of very small importer as required per 21 CFR 1.512(b)(1)(i).  If this section applies and you chose to comply with the requirements in paragraph (b) of this section, you also are required to comply with the requirements in sections 1.502, 1.503, and 1.509, but you are not required to comply with the requirements in sections 1.504 through 1.508 or 1.510.  In addition, for each food you import, you must obtain written assurance, before importing the food and at least every two years thereafter, that your foreign supplier is producing the food in compliance with processes and procedures that provide at least the same level of public health protection as those required under section 418 and 419 of the FD&C Act, if either is applicable, and the implementing regulations, and is producing the food in compliance with sections 402 and 403(w) (if applicable) of the FD&C Act (21 CFR 1.512(b)(3)(i)).\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp style=\"text-align:justify\">\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"font-family:Calibri,sans-serif\">\u003Cspan style=\"font-size:12.0pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">Please send your reply to Food and Drug Administration, Attention: Nabeela J. Chaudhry, Compliance Officer, Division of West Coast Imports, 1 World Trade Center, Suite 300, Long Beach, CA 90831.  If you have any questions regarding this letter, you may contact Nabeela Chaudhry via email at \u003C\u002Fspan>\u003C\u002Fspan>\u003Ca href=\"mailto:nabeela.chaudhry@fda.hhs.gov\" style=\"color:blue; text-decoration:underline\">\u003Cspan style=\"font-size:12.0pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">nabeela.chaudhry@fda.hhs.gov\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fa>\u003Cspan style=\"font-size:12.0pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">.  Please reference CMS #616100\u003Ci> \u003C\u002Fi>on any documents or records you provide to us and within the subject line of any email correspondence you send to us.\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"font-family:Calibri,sans-serif\">\u003Cspan style=\"font-size:12.0pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">Sincerely,\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u002FS\u002F\u003Cbr>\n\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"font-family:Calibri,sans-serif\">\u003Cspan style=\"font-size:12.0pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">Dr. Kathleen Turner\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cbr>\n\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"font-family:Calibri,sans-serif\">\u003Cspan style=\"font-size:12.0pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">Program Division Director\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cbr>\n\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"font-family:Calibri,sans-serif\">\u003Cspan style=\"font-size:12.0pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">Division of West Coast Imports\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\n\u003C!--BEGIN QUALTRICS WEBSITE FEEDBACK SNIPPET-->\n\u003C!--BEGIN QUALTRICS WEBSITE FEEDBACK SNIPPET-->\n\n\n\n              \n                                            \n              \n            ","Delivery Method:\n\nUnited Parcel Service\n\nProduct:\n\nFood & Beverages\n\nRecipient:\n\nRecipient Name\n\nRoobina Raja and Roobina Sardar\n\nRecipient Title\n\nCo-Owners\n\nJD's Market Inc.\n\n4419 200th Street SW\n\nLynnwood, WA 98036-6601\n\nUnited States\n\nIssuing Office:\n\nDivision of West Coast Imports\n\nUnited States\n\nWARNING LETTER\n\nOctober 15, 2021\n\nRe: CMS # 616100\n\nDear Ms. Raja and Ms. Sardar:\n\nOn May 3 and May 17-21, 2021, the Food and Drug Administration (FDA) conducted a remote Foreign Supplier Verification Program (FSVP) inspection of JD’s Market Inc., located at 4419 200th Street SW Lynnwood, WA 98036-6601. We also conducted an inspection on March 1, 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 implementing FSVP regulation in 21 CFR part 1 subpart L.\n\nThe FSVP regulation requires that importers perform certain risk-based activities to verify that human and\u002For 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:\u002F\u002Fwww.fda.gov\u002Ffood\u002Ffood-safety-modernization-act-fsma\u002Ffsma-final-rule-foreign-supplier-verification-programs-fsvp-importers-food-humans-and-animals.\n\nDuring the most recent inspection, we found that you are not in compliance with the requirements of 21 CFR part 1 subpart L for the foods you import. Because of these significant violations, you are not in compliance with section 805 of the FD&C Act.\n\nAt the conclusion of the inspection, our investigator provided you with a Form FDA 483a, FSVP Observations.\n\nWe have not received your response to the Form FDA 483a issued on May 21, 2021.\n\nYour significant violations of the FSVP regulation are as follows:\n\nYou did not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a). Specifically, you did not develop, maintain, and follow an FSVP for any of the foods you import, including the following foods:\n\nJumbo Raisins imported from (b)(4)\n\nDry Plums imported from (b)(4)\n\nAfter Meal Snacks imported from (b)(4)\n\nThe 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.\n\nThis letter notifies you of our concerns and provides you an opportunity to address them. If you do not adequately address this matter, 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 you import for which you appear to be in violation of section 805. We may place the foods you import into the United States on detention without physical examination (DWPE) when you import the foods. You can find DWPE information relating to FSVP in Import Alert #99-41 at http:\u002F\u002Fwww.accessdata.fda.gov\u002Fcms_ia\u002Fialist.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 (21 U.S.C. 331(zz)).\n\nYou 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 any 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 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.\n\nWe note that you may meet the definition of a “very small importer” under 21 CFR 1.500. If you meet the definition, you are still required to follow FSVP requirements. If you are a very small importer and you choose to comply with the modified requirements in 21 CFR 1.512, you must document that you meet the definition of very small importer as required per 21 CFR 1.512(b)(1)(i). If this section applies and you chose to comply with the requirements in paragraph (b) of this section, you also are required to comply with the requirements in sections 1.502, 1.503, and 1.509, but you are not required to comply with the requirements in sections 1.504 through 1.508 or 1.510. In addition, for each food you import, you must obtain written assurance, before importing the food and at least every two years thereafter, that your foreign supplier is producing the food in compliance with processes and procedures that provide at least the same level of public health protection as those required under section 418 and 419 of the FD&C Act, if either is applicable, and the implementing regulations, and is producing the food in compliance with sections 402 and 403(w) (if applicable) of the FD&C Act (21 CFR 1.512(b)(3)(i)).\n\nPlease send your reply to Food and Drug Administration, Attention: Nabeela J. Chaudhry, Compliance Officer, Division of West Coast Imports, 1 World Trade Center, Suite 300, Long Beach, CA 90831. If you have any questions regarding this letter, you may contact Nabeela Chaudhry via email at nabeela.chaudhry@fda.hhs.gov. Please reference CMS #616100 on any documents or records you provide to us and within the subject line of any email correspondence you send to us.\n\nSincerely,\n\n\u002FS\u002F\n\nDr. Kathleen Turner\n\nProgram Division Director\n\nDivision of West Coast Imports","2026-08-20T02:26:27.081+00:00",[23,24,25,9,10,26,26,26],"\u003Ctime datetime=\"2021-11-16T14:20:00Z\">11\u002F16\u002F2021\u003C\u002Ftime>\n","\u003Ctime datetime=\"2021-10-15T04:00:00Z\">10\u002F15\u002F2021\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fjds-market-inc-616100-10152021\">JD's Market Inc.\u003C\u002Fa>","","2026-08-18T06:42:29.386127+00:00","2026-08-20T02:26:29.194712+00:00",{"510k":30,"classification":31,"enforcement":32,"event":33,"pma":34,"warning_letter":35},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:58:35.995+00:00","2026-08-18T06:36:30.549+00:00","2026-08-20T03:28:02.95+00:00"]