[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-shouly-import-corp-731741-06262026":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},21727,"shouly-import-corp-731741-06262026","Warning Letter","Shouly Import Corp.",null,"Office of Inspections and Investigations","Foreign Supplier Verification Program (FSVP)","2026-09-22","2026-06-26","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fshouly-import-corp-731741-06262026","731741","Food & Beverages","Via Email","Mohammad Shouly","\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\">Via Email\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\">Mohammad Shouly\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\">Partner\u002FOwner\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n          \n            \u003Cdd>Shouly Import Corp.\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">371 Lakeview Ave\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"locality\">Clifton\u003C\u002Fspan>, \u003Cspan class=\"administrative-area\">NJ\u003C\u002Fspan> \u003Cspan class=\"postal-code\">07011-4037\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"country\">United States\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n          \n          \n            \n            \u003Cdd>\u003C!-- Loop this field. For FDA Office content type. Display the Other contact channel is a dd span with an icon-->\n\n    \u003C\u002Fdd>\u003Cdd>\u003Cspan class=\"fa fa-envelope\" aria-hidden=\"true\">\u003C\u002Fspan>\u003Ca href=\"mailto:(b)(6), (b)(7)(C)\"> (b)(6), (b)(7)(C)\u003C\u002Fa>\u003C\u002Fdd>\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>Office of Inspections and Investigations\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>June 26, 2026\u003C\u002Fp>\u003Cp class=\"text-align-center\">\u003Cstrong>WARNING LETTER\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp class=\"text-align-center\">RE: CMS# 731741\u003C\u002Fp>\u003Cp>Dear Mr. Mohammad Shouly:\u003C\u002Fp>\u003Cp>On April 30, 2026 the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Shouly Import Corp., 371 Lakeview Ave, Clifton, NJ 07011-4037. This inspection was 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\u002Fp>\u003Cp>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 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\u002Fp>\u003Cp>During the 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. At the conclusion of the inspection, our investigator provided you with a Form FDA 483a FSVP Observations.\u003C\u002Fp>\u003Cp>We acknowledge receipt of your response, dated May 13, 2026, in which you stated Shouly Import Corp has engaged a qualified FSVP consultant and initiated corrective actions, including reviewing all imported products and suppliers, developing product-specific FSVP documentation, collecting supplier food safety records, implementing written procedures, and establishing ongoing verification activities. Due to the scope of the work, the company expects to complete full FSVP implementation for all imported products within six months and is committed to maintaining compliance with FDA requirements going forward. We are unable to evaluate the adequacy of your response because you have not provided any supporting documentation demonstrating your corrective actions. To date, no additional FSVP documents have been received by FDA.\u003C\u002Fp>\u003Cp>Your significant violations of the FSVP regulation are as follows:\u003Cbr>You did not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR part 1.502(a). Specifically, you did not develop an FSVP for any of the foods you import, including each of the following foods:\u003C\u002Fp>\u003Cul>\u003Cli>Roasted White Sesame imported from \u003Cstrong>(b)(4)\u003C\u002Fstrong>, located in \u003Cstrong>(b)(4)\u003C\u002Fstrong>\u003C\u002Fli>\u003Cli>Feta 500GM imported from \u003Cstrong>(b)(4)\u003C\u002Fstrong>, located in \u003Cstrong>(b)(4)\u003C\u002Fstrong>\u003C\u002Fli>\u003Cli>Classic Baklava imported from \u003Cstrong>(b)(4)\u003C\u002Fstrong>, located in \u003Cstrong>(b)(4)\u003C\u002Fstrong>\u003C\u002Fli>\u003C\u002Ful>\u003Cp>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\u002Fp>\u003Cp>\u003Cstrong>(b)(3)(A)\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>As a responsible official of a facility that manufactures\u002Fprocesses, packs, or holds food for human or animal consumption in the United States, you are responsible for ensuring that your overall operation and the products you distribute are in compliance with the law.\u003C\u002Fp>\u003Cp>\u003Cstrong>(b)(3)(A)\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>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 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)).\u003C\u002Fp>\u003Cp>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 working days, you should explain the reason for your delay and state when you will correct any remaining violations.\u003C\u002Fp>\u003Cp>Please send your reply to Food and Drug Administration, Attention: Jananiga Vanniyasingam, Compliance Officer, Division of Northeast Imports: oiioiodneiwlresponses@fda.hhs.gov. Please also cc (carbon copy) Jananiga.vanniyasingam@fda.hhs.gov. If you have any questions regarding this letter, you may contact Compliance Officer Vanniyasingam via email at Jananiga.vanniyasingam@fda.hhs.gov. Please reference CMS # 731741 on any documents or records you provide to us and on the subject line of any email correspondence you send to us.\u003C\u002Fp>\u003Cp>Sincerely,\u003Cbr>\u002FS\u002F\u003C\u002Fp>\u003Cp>CDR Joseph S. Tomao\u003Cbr>Program Division Director\u003Cbr>Division of Northeast Imports\u003C\u002Fp>\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\nVia Email\n\nProduct:\n\nFood & Beverages\n\nRecipient:\n\nRecipient Name\n\nMohammad Shouly\n\nRecipient Title\n\nPartner\u002FOwner\n\nShouly Import Corp.\n\n371 Lakeview Ave\n\nClifton, NJ 07011-4037\n\nUnited States\n\n(b)(6), (b)(7)(C)\n\nIssuing Office:\n\nOffice of Inspections and Investigations\n\nUnited States\n\nJune 26, 2026\nWARNING LETTER\nRE: CMS# 731741\nDear Mr. Mohammad Shouly:\nOn April 30, 2026 the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Shouly Import Corp., 371 Lakeview Ave, Clifton, NJ 07011-4037. This inspection was 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.\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.\nDuring the 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. At the conclusion of the inspection, our investigator provided you with a Form FDA 483a FSVP Observations.\nWe acknowledge receipt of your response, dated May 13, 2026, in which you stated Shouly Import Corp has engaged a qualified FSVP consultant and initiated corrective actions, including reviewing all imported products and suppliers, developing product-specific FSVP documentation, collecting supplier food safety records, implementing written procedures, and establishing ongoing verification activities. Due to the scope of the work, the company expects to complete full FSVP implementation for all imported products within six months and is committed to maintaining compliance with FDA requirements going forward. We are unable to evaluate the adequacy of your response because you have not provided any supporting documentation demonstrating your corrective actions. To date, no additional FSVP documents have been received by FDA.\nYour significant violations of the FSVP regulation are as follows:\nYou did not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR part 1.502(a). Specifically, you did not develop an FSVP for any of the foods you import, including each of the following foods:\nRoasted White Sesame imported from (b)(4), located in (b)(4)\nFeta 500GM imported from (b)(4), located in (b)(4)\nClassic Baklava imported from (b)(4), located in (b)(4)\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(b)(3)(A)\nAs a responsible official of a facility that manufactures\u002Fprocesses, packs, or holds food for human or animal consumption in the United States, you are responsible for ensuring that your overall operation and the products you distribute are in compliance with the law.\n(b)(3)(A)\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)).\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 working days, you should explain the reason for your delay and state when you will correct any remaining violations.\nPlease send your reply to Food and Drug Administration, Attention: Jananiga Vanniyasingam, Compliance Officer, Division of Northeast Imports: oiioiodneiwlresponses@fda.hhs.gov. Please also cc (carbon copy) Jananiga.vanniyasingam@fda.hhs.gov. If you have any questions regarding this letter, you may contact Compliance Officer Vanniyasingam via email at Jananiga.vanniyasingam@fda.hhs.gov. Please reference CMS # 731741 on any documents or records you provide to us and on the subject line of any email correspondence you send to us.\nSincerely,\n\u002FS\u002F\nCDR Joseph S. Tomao\nProgram Division Director\nDivision of Northeast Imports","2026-10-14T12:36:55.598+00:00",[23,24,25,9,10,26,26,26],"\u003Ctime datetime=\"2026-09-22T04:00:00Z\">09\u002F22\u002F2026\u003C\u002Ftime>\n","\u003Ctime datetime=\"2026-06-26T04:00:00Z\">06\u002F26\u002F2026\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fshouly-import-corp-731741-06262026\">Shouly Import Corp.\u003C\u002Fa>","","2026-10-14T12:31:16.41489+00:00","2026-10-14T14:44:01.489557+00:00",{"510k":30,"classification":31,"enforcement":32,"event":33,"event_backfill":34,"pma":35,"warning_letter":36},"2026-10-12T02:00:50.914+00:00","2026-10-12T02:00:38.521+00:00","2026-10-12T02:00:45.002+00:00","2026-10-14T04:02:53.8+00:00","2026-09-07T05:17:28.839+00:00","2026-10-12T02:00:52.377+00:00","2026-10-14T14:44:02.318+00:00"]