[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-bc-food-la-llc-dba-b-c-food-co-654872-07242023":3,"fda-latest-sync-dates":30},{"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":28,"updated_at":29},1985,"bc-food-la-llc-dba-b-c-food-co-654872-07242023","Warning Letter","BC Food LA, LLC, DBA B & C Food Co.",null,"Division of West Coast Imports","Foreign Supplier Verification Program (FSVP)","2023-07-25","2023-07-24","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fbc-food-la-llc-dba-b-c-food-co-654872-07242023","654872","Food & Beverages","Via Express Delivery","Allen L. Pung","\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 Express Delivery\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\">Allen L. Pung\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\u002FManager\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n          \n            \u003Cdd>BC Food LA, LLC, DBA B & C Food Co.\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">2662 Seaman Avenue\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"locality\">El Monte\u003C\u002Fspan>, \u003Cspan class=\"administrative-area\">CA\u003C\u002Fspan> \u003Cspan class=\"postal-code\">91733-1930\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  \u003Cdiv class=\"field field--name-field-issuing-office-paragraph field--type-entity-reference-revisions field--label-above\">\n    \u003Cdiv class=\"field--label\">Secondary Issuing Offices\u003C\u002Fdiv>\n          \u003Cdiv class=\"field--items\">\n              \u003Cdiv class=\"field--item\">    \u003Cbr>\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\u003C\u002Fdiv>\n              \u003C\u002Fdiv>\n      \u003C\u002Fdiv>\n\n    \u003C\u002Fdl>\n  \u003C\u002Fdiv>  \n      \n\u003C\u002Fdiv>\n\n \n\n \n\n\u003Chr>\n\n\u003Cp>July 24, 2023\u003C\u002Fp>\n\n\u003Cp class=\"text-align-center\">\u003Cstrong>WARNING LETTER\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp class=\"text-align-center\">Re: CMS 654872\u003C\u002Fp>\n\n\u003Cp>Dear Mr. Allen L. Pung:\u003C\u002Fp>\n\n\u003Cp>From February 13 to 23, 2023, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Programs (FSVP) inspection of BC Food LA, LLC, DBA B & C Food Co., located at 2662 Seaman Avenue, El Monte, CA. We also conducted an inspection on July 11, 2019 and on July 9 to 14, 2022. 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 https:\u002F\u002Fwww.fda.gov\u002Ffood\u002Ffood-safety-modernization-act-fsma\u002Ffsma-final-rule-foreign-supplier-verification-programs-fsvp-importers-food-humans-and-animals\u003Cbr>\n\u003Cbr>\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 from the foreign suppliers indicated in the list provided during the inspection. 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. We have not received your response to the Form FDA 483a issued on February 23, 2023.\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 the foods you import indicated in the list provided during the inspection, including the following foods:\u003C\u002Fp>\n\n\u003Cul>\n\t\u003Cli>Cookie, imported from \u003Cstrong>(b)(4)\u003C\u002Fstrong>, located in \u003Cstrong>(b)(4)\u003C\u002Fstrong>\u003C\u002Fli>\n\t\u003Cli>Duck eggs, imported from \u003Cstrong>(b)(4)\u003C\u002Fstrong>, located in \u003Cstrong>(b)(4)\u003C\u002Fstrong>\u003C\u002Fli>\n\t\u003Cli>Gourd, imported from \u003Cstrong>(b)(4)\u003C\u002Fstrong>, located in \u003Cstrong>(b)(4)\u003C\u002Fstrong>\u003C\u002Fli>\n\t\u003Cli>Fruit filled cookies, plain cookies, biscuits, wafers and cakes and other, imported from \u003Cstrong>(b)(4)\u003C\u002Fstrong>, located in \u003Cstrong>(b)(4)\u003C\u002Fstrong>\u003C\u002Fli>\n\t\u003Cli>Nut plain cookies, biscuits and wafers, imported from \u003Cstrong>(b)(4)\u003C\u002Fstrong> located in \u003Cstrong>(b)(4)\u003C\u002Fstrong>\u003C\u002Fli>\n\t\u003Cli>Fruit filled cookies, biscuits wafters, filled, iced cookies, imported from \u003Cstrong>(b)(4)\u003C\u002Fstrong>, located in \u003Cstrong>(b)(4)\u003C\u002Fstrong>\u003C\u002Fli>\n\t\u003Cli>Noodles wheat and soy, imported from \u003Cstrong>(b)(4)\u003C\u002Fstrong>, located in \u003Cstrong>(b)(4)\u003C\u002Fstrong>\u003C\u002Fli>\n\t\u003Cli>Bean Thread, imported from \u003Cstrong>(b)(4)\u003C\u002Fstrong>, located in \u003Cstrong>(b)(4)\u003C\u002Fstrong>\u003C\u002Fli>\n\u003C\u002Ful>\n\n\u003Cp>Because of these significant violations, you are not in compliance with section 805 of the FD&C Act.\u003C\u002Fp>\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 with the opportunity to promptly correct the above violations. 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>\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 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\u002Fp>\n\n\u003Cp>Please send your reply to Food and Drug Administration, Attention: Lisa K. Capron, Compliance Officer, Division of West Coast Imports, 19701 Fairchild Road, Irvine, California, 92612. If you have any questions regarding this letter, you may contact Lisa K. Capron via email at lisa.capron@fda.hhs.gov.\u003C\u002Fp>\n\n\u003Cp>Please reference CMS 654872 on any documents or records you provide to us and\u002F or 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>Dr. Kathleen Turner\u003Cbr>\nProgram Division Director\u003Cbr>\nDivision of West Coast 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 Express Delivery\n\nProduct:\n\nFood & Beverages\n\nRecipient:\n\nRecipient Name\n\nAllen L. Pung\n\nRecipient Title\n\nOwner\u002FManager\n\nBC Food LA, LLC, DBA B & C Food Co.\n\n2662 Seaman Avenue\n\nEl Monte, CA 91733-1930\n\nUnited States\n\nIssuing Office:\n\nDivision of West Coast Imports\n\nUnited States\n\nSecondary Issuing Offices\n\nUnited States\n\nJuly 24, 2023\n\nWARNING LETTER\n\nRe: CMS 654872\n\nDear Mr. Allen L. Pung:\n\nFrom February 13 to 23, 2023, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Programs (FSVP) inspection of BC Food LA, LLC, DBA B & C Food Co., located at 2662 Seaman Avenue, El Monte, CA. We also conducted an inspection on July 11, 2019 and on July 9 to 14, 2022. 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 from the foreign suppliers indicated in the list provided during the inspection. 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. We have not received your response to the Form FDA 483a issued on February 23, 2023.\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 the foods you import indicated in the list provided during the inspection, including the following foods:\n\nCookie, imported from (b)(4), located in (b)(4)\n\nDuck eggs, imported from (b)(4), located in (b)(4)\n\nGourd, imported from (b)(4), located in (b)(4)\n\nFruit filled cookies, plain cookies, biscuits, wafers and cakes and other, imported from (b)(4), located in (b)(4)\n\nNut plain cookies, biscuits and wafers, imported from (b)(4) located in (b)(4)\n\nFruit filled cookies, biscuits wafters, filled, iced cookies, imported from (b)(4), located in (b)(4)\n\nNoodles wheat and soy, imported from (b)(4), located in (b)(4)\n\nBean Thread, imported from (b)(4), located in (b)(4)\n\nBecause of these significant violations, you are not in compliance with section 805 of the FD&C Act.\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 with the opportunity to promptly correct the above violations. 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\nPlease send your reply to Food and Drug Administration, Attention: Lisa K. Capron, Compliance Officer, Division of West Coast Imports, 19701 Fairchild Road, Irvine, California, 92612. If you have any questions regarding this letter, you may contact Lisa K. Capron via email at lisa.capron@fda.hhs.gov.\n\nPlease reference CMS 654872 on any documents or records you provide to us and\u002F or 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","2026-08-20T00:51:14.707+00:00",[23,24,25,26,10,27,27,27],"\u003Ctime datetime=\"2023-07-25T04:00:00Z\">07\u002F25\u002F2023\u003C\u002Ftime>\n","\u003Ctime datetime=\"2023-07-24T04:00:00Z\">07\u002F24\u002F2023\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fbc-food-la-llc-dba-b-c-food-co-654872-07242023\">BC Food LA, LLC, DBA B & C Food Co.\u003C\u002Fa>"," Division of West Coast Imports","","2026-08-18T06:42:28.994808+00:00","2026-08-20T02:24:56.185295+00:00",{"510k":31,"classification":32,"enforcement":33,"event":34,"pma":35,"warning_letter":36},"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"]