[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-la-serranita-import-and-export-llc-633743-09192022":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},2314,"la-serranita-import-and-export-llc-633743-09192022","Warning Letter","La Serranita Import and Export LLC",null,"Division of Northeast Imports","Foreign Supplier Verification Program (FSVP)","2022-11-29","2022-09-19","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fla-serranita-import-and-export-llc-633743-09192022","633743","Food & Beverages","VIA EMAIL AND UNITED PARCEL SERVICE","Hugo Enriquez","\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 AND 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\">Hugo Enriquez\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\">Owner\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n          \n            \u003Cdd>La Serranita Import and Export LLC\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">618 Westfield Ave Apt 307\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"locality\">Elizabeth\u003C\u002Fspan>, \u003Cspan class=\"administrative-area\">NJ\u003C\u002Fspan> \u003Cspan class=\"postal-code\">07208\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 Northeast 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 class=\"text-align-center\">\u003Cstrong>WARNING LETTER\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp class=\"text-align-center\">CMS# 633743\u003C\u002Fp>\n\n\u003Cp>Dear Mr. Hugo Enriquez:\u003C\u002Fp>\n\n\u003Cp>On March 30 through April 13, 2022, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of La Serranita Import and Export LLC located at 618 Westfield Avenue, Apartment 307, Elizabeth, NJ 07208. We also conducted an inspection on April 9 through May 7, 2020. 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\u002Fp>\n\n\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 \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\">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\u002Fa>.\u003C\u002Fp>\n\n\u003Cp>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 foods you import, including your frozen corn cobs imported from \u003Cstrong>(b)(4)\u003C\u002Fstrong>, located in \u003Cstrong>(b)(4)\u003C\u002Fstrong>; frozen whole yellow hot pepper imported from \u003Cstrong>(b)(4)\u003C\u002Fstrong>, located in \u003Cstrong>(b)(4)\u003C\u002Fstrong>; and special white cheese of Cayambe imported from \u003Cstrong>(b)(4)\u003C\u002Fstrong>, located in \u003Cstrong>(b)(4)\u003C\u002Fstrong>. Because of these significant violations, you are not in compliance with section 805 of the FD&C Act.\u003C\u002Fp>\n\n\u003Cp>At the conclusion of the inspection, our investigator provided you with a Form FDA 483a, FSVP Observations.\u003C\u002Fp>\n\n\u003Cp>We acknowledge receipt of your 483a Response on May 5, 2022, which included the following three documents:\u003C\u002Fp>\n\n\u003Cp>1. \u003Cstrong>(b)(4)\u003C\u002Fstrong>\u003Cbr>\n2. \u003Cstrong>(b)(4)\u003C\u002Fstrong>\u003Cbr>\n3. \u003Cstrong>(b)(4)\u003C\u002Fstrong>\u003Cbr>\n“\u003Cstrong>(b)(4)\u003C\u002Fstrong>” appears to be a copy of the \u003Cstrong>(b)(3)(A)\u003C\u002Fstrong> for \u003Cstrong>(b)(4)\u003C\u002Fstrong>, located in \u003Cstrong>(b)(4)\u003C\u002Fstrong>.  \u003Cstrong>(b)(4)\u003C\u002Fstrong> is in a language other than English. The document appears to be a certificate of analysis for frozen corn from a third-party laboratory for \u003Cstrong>(b)(4)\u003C\u002Fstrong> is in a language other than English. The document appears to be a certificate of analysis for frozen peppers from a third-party laboratory for \u003Cstrong>(b)(4)\u003C\u002Fstrong>. However, \u003Cstrong>(b)(4)\u003C\u002Fstrong> was not declared as the manufacturer for any foods covered during the inspection that concluded on April 13, 2022. Further, you did not provide any information about your review of these documents or how these documents would be used as part of an FSVP.\u003C\u002Fp>\n\n\u003Cp>Your significant violations of the FSVP regulation are as follows:\u003C\u002Fp>\n\n\u003Cp>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 an FSVP for any of the foods you import, including each of the following foods:\u003C\u002Fp>\n\n\u003Cul>\n\t\u003Cli>Frozen Corn Cobs imported from \u003Cstrong>(b)(4)\u003C\u002Fstrong>, located in \u003Cstrong>(b)(4)\u003C\u002Fstrong>\u003C\u002Fli>\n\t\u003Cli>Frozen Whole Yellow Hot Pepper imported from \u003Cstrong>(b)(4)\u003C\u002Fstrong>, located in \u003Cstrong>(b)(4)\u003C\u002Fstrong>\u003C\u002Fli>\n\t\u003Cli>Special White Cheese of Cayambe imported from \u003Cstrong>(b)(4)\u003C\u002Fstrong>, located in \u003Cstrong>(b)(4)\u003C\u002Fstrong>\u003C\u002Fli>\n\u003C\u002Ful>\n\n\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>\n\n\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 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 \u003Ca href=\"https:\u002F\u002Fwww.accessdata.fda.gov\u002Fcms_ia\u002Fialist.html\">https:\u002F\u002Fwww.accessdata.fda.gov\u002Fcms_ia\u002Fialist.html\u003C\u002Fa>. 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. 321(zz)).\u003C\u002Fp>\n\n\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 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 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 address any remaining violations.\u003C\u002Fp>\n\n\u003Cp>Please send your reply to Food and Drug Administration, Attention: Russell Vandermark, FDA Compliance Officer, Division of Northeast Imports: ORAOEIONEIMPORTSWLResponses@fda.hhs.gov. Please also cc (carbon copy) Russell.Vandermark@fda.hhs.gov. If you have any questions regarding this letter, you may contact Compliance Officer Vandermark via email at Russell.Vandermark@fda.hhs.gov. Please reference CMS # 633743 on any documents or records you provide to us and\u002For within the subject line of any email correspondence you send to us.\u003C\u002Fp>\n\n\u003Cp>Sincerely,\u003Cbr>\n\u002FS\u002F\u003C\u002Fp>\n\n\u003Cp>CDR Joseph Tomao\u003Cbr>\nActing Program Division Director\u003Cbr>\nDivision of Northeast Imports\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\nVIA EMAIL AND UNITED PARCEL SERVICE\n\nProduct:\n\nFood & Beverages\n\nRecipient:\n\nRecipient Name\n\nHugo Enriquez\n\nRecipient Title\n\nOwner\n\nLa Serranita Import and Export LLC\n\n618 Westfield Ave Apt 307\n\nElizabeth, NJ 07208\n\nUnited States\n\nIssuing Office:\n\nDivision of Northeast Imports\n\nUnited States\n\nWARNING LETTER\n\nCMS# 633743\n\nDear Mr. Hugo Enriquez:\n\nOn March 30 through April 13, 2022, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of La Serranita Import and Export LLC located at 618 Westfield Avenue, Apartment 307, Elizabeth, NJ 07208. We also conducted an inspection on April 9 through May 7, 2020. 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, including your frozen corn cobs imported from (b)(4), located in (b)(4); frozen whole yellow hot pepper imported from (b)(4), located in (b)(4); and special white cheese of Cayambe imported from (b)(4), located in (b)(4). 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 acknowledge receipt of your 483a Response on May 5, 2022, which included the following three documents:\n\n1. (b)(4)\n\n2. (b)(4)\n\n3. (b)(4)\n\n“(b)(4)” appears to be a copy of the (b)(3)(A) for (b)(4), located in (b)(4). (b)(4) is in a language other than English. The document appears to be a certificate of analysis for frozen corn from a third-party laboratory for (b)(4) is in a language other than English. The document appears to be a certificate of analysis for frozen peppers from a third-party laboratory for (b)(4). However, (b)(4) was not declared as the manufacturer for any foods covered during the inspection that concluded on April 13, 2022. Further, you did not provide any information about your review of these documents or how these documents would be used as part of an FSVP.\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 an FSVP for any of the foods you import, including each of the following foods:\n\nFrozen Corn Cobs imported from (b)(4), located in (b)(4)\n\nFrozen Whole Yellow Hot Pepper imported from (b)(4), located in (b)(4)\n\nSpecial White Cheese of Cayambe imported from (b)(4), located in (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 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 https:\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. 321(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 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 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 address any remaining violations.\n\nPlease send your reply to Food and Drug Administration, Attention: Russell Vandermark, FDA Compliance Officer, Division of Northeast Imports: ORAOEIONEIMPORTSWLResponses@fda.hhs.gov. Please also cc (carbon copy) Russell.Vandermark@fda.hhs.gov. If you have any questions regarding this letter, you may contact Compliance Officer Vandermark via email at Russell.Vandermark@fda.hhs.gov. Please reference CMS # 633743 on any documents or records you provide to us and\u002For within the subject line of any email correspondence you send to us.\n\nSincerely,\n\n\u002FS\u002F\n\nCDR Joseph Tomao\n\nActing Program Division Director\n\nDivision of Northeast Imports","2026-08-20T01:23:57.846+00:00",[23,24,25,9,10,26,26,26],"\u003Ctime datetime=\"2022-11-29T14:20:00Z\">11\u002F29\u002F2022\u003C\u002Ftime>\n","\u003Ctime datetime=\"2022-09-19T04:00:00Z\">09\u002F19\u002F2022\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fla-serranita-import-and-export-llc-633743-09192022\">La Serranita Import and Export LLC\u003C\u002Fa>","","2026-08-18T06:42:29.145918+00:00","2026-08-20T02:24:56.344395+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"]