[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-bo-wah-enterprises-inc-736539-08132026":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},21711,"bo-wah-enterprises-inc-736539-08132026","Warning Letter","Bo Wah Enterprises Inc",null,"Office of Inspections and Investigations","Foreign Supplier Verification Program (FSVP)","2026-09-29","2026-08-13","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fbo-wah-enterprises-inc-736539-08132026","736539","Food & Beverages","Via Express Delivery","Danny Y.W. Au","\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\">Danny Y.W. Au\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\">President \u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n          \n            \u003Cdd>Bo Wah Enterprises Inc\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">1037 Maunakea St\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"locality\">Honolulu\u003C\u002Fspan>, \u003Cspan class=\"administrative-area\">HI\u003C\u002Fspan> \u003Cspan class=\"postal-code\">96817-5130\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>August 13, 2026\u003C\u002Fp>\u003Cp class=\"text-align-center\">\u003Cstrong>WARNING LETTER\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp class=\"text-align-center\">Re: CMS 736539\u003C\u002Fp>\u003Cp>Dear Mr. Au:\u003C\u002Fp>\u003Cp>On June 24, June 30, and July 1, 2026, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of BO WAH ENTERPRISES INC, 1037 Maunakea St, Honolulu, HI 96817-5130. 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.\u003C\u002Fp>\u003Cp>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 July 13, 2026, in which you stated your firm \u003Cstrong>(b)(4)\u003C\u002Fstrong> develop your FSVP, requested HACCP and \u003Cstrong>(b)(4)\u003C\u002Fstrong> certificates from your foreign suppliers, and plans to send a firm member\u002Femployee to \u003Cstrong>(b)(4)\u003C\u002Fstrong> training. 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:\u003C\u002Fp>\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>\u003Cul>\u003Cli>\u003Cstrong>(b)(4)\u003C\u002Fstrong> Huai Shan (Chinese Yam), imported from \u003Cstrong>(b)(4)\u003C\u002Fstrong> located in \u003Cstrong>(b)(4)\u003C\u002Fstrong>\u003C\u002Fli>\u003Cli>\u003Cstrong>(b)(4)\u003C\u002Fstrong> Golden Mushroom, imported from \u003Cstrong>(b)(4)\u003C\u002Fstrong> located in \u003Cstrong>(b)(4)\u003C\u002Fstrong>\u003C\u002Fli>\u003Cli>\u003Cstrong>(b)(4)\u003C\u002Fstrong> Sesame Paste, imported from \u003Cstrong>(b)(4)\u003C\u002Fstrong> located in \u003Cstrong>(b)(4)\u003C\u002Fstrong>\u003C\u002Fli>\u003C\u002Ful>\u003Cp>For thermally processed low-acid foods packaged in hermetically sealed containers (low-acid canned foods), with respect to those microbiological hazards that are controlled by following 21 CFR part 113, you must verify and document that the food was produced in accordance with 21 CFR part 113, as required by 21 CFR 1.502(b)(1). However, you did not verify and document that the canned food products you import, including but not limited to \u003Cstrong>(b)(4)\u003C\u002Fstrong> Golden Mushroom, imported from \u003Cstrong>(b)(4) \u003C\u002Fstrong>located in \u003Cstrong>(b)(4)\u003C\u002Fstrong> were produced in accordance with 21 CFR part 113 (regarding thermally processed low-acid foods packaged in hermetically sealed containers), as required by 21 CFR 1.502(b)(1).\u003C\u002Fp>\u003Cp>During our inspection close-out you provided the following documents:\u003C\u002Fp>\u003Cul>\u003Cli>HACCP plan containing a hazard analysis, a third-party audit report, and certificate from your foreign supplier \u003Cstrong>(b)(4)\u003C\u002Fstrong> located in \u003Cstrong>(b)(4)\u003C\u002Fstrong>\u003C\u002Fli>\u003Cli>A Certificate of Analysis (COA) and a HACCP certificate from your foreign supplier \u003Cstrong>(b)(4)\u003C\u002Fstrong> located in \u003Cstrong>(b)(4)\u003C\u002Fstrong>; this document identified the US Importer as \u003Cstrong>(b)(4)\u003C\u002Fstrong>\u003C\u002Fli>\u003C\u002Ful>\u003Cp>You stated you obtained these from your import liaisons. However, it is not clear how these documents would apply to your FSVP program, and you did not explain how they would apply to your FSVP program.\u003C\u002Fp>\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>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.\u003C\u002Fp>\u003Cp>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: Sandra K. Wangen Compliance Officer, Division of West Coast Imports, 934 Broadway, Suite 101, Tacoma, WA 98402; or via email to wcid@fda.hhs.gov, Attention: Sandra K. Wangen, Compliance Officer. If you have any questions regarding this letter, you may contact Sandra K. Wangen via email at sandra.wangen@fda.hhs.gov. Please reference CMS # 736539 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>\u003Cp>Sincerely,\u003Cbr>\u002FS\u002F\u003Cbr>Dr. Kathleen Turner\u003Cbr>Program Division Director\u003Cbr>Division of West Coast 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 Express Delivery\n\nProduct:\n\nFood & Beverages\n\nRecipient:\n\nRecipient Name\n\nDanny Y.W. Au\n\nRecipient Title\n\nPresident\n\nBo Wah Enterprises Inc\n\n1037 Maunakea St\n\nHonolulu, HI 96817-5130\n\nUnited States\n\n(b)(6), (b)(7)(C)\n\nIssuing Office:\n\nOffice of Inspections and Investigations\n\nUnited States\n\nAugust 13, 2026\nWARNING LETTER\nRe: CMS 736539\nDear Mr. Au:\nOn June 24, June 30, and July 1, 2026, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of BO WAH ENTERPRISES INC, 1037 Maunakea St, Honolulu, HI 96817-5130. 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.\nAt the conclusion of the inspection, our investigator provided you with a Form FDA 483a FSVP Observations.\nWe acknowledge receipt of your response, dated July 13, 2026, in which you stated your firm (b)(4) develop your FSVP, requested HACCP and (b)(4) certificates from your foreign suppliers, and plans to send a firm member\u002Femployee to (b)(4) training. 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 1.502(a). Specifically, you did not develop an FSVP for any of the foods you import, including each of the following foods:\n(b)(4) Huai Shan (Chinese Yam), imported from (b)(4) located in (b)(4)\n(b)(4) Golden Mushroom, imported from (b)(4) located in (b)(4)\n(b)(4) Sesame Paste, imported from (b)(4) located in (b)(4)\nFor thermally processed low-acid foods packaged in hermetically sealed containers (low-acid canned foods), with respect to those microbiological hazards that are controlled by following 21 CFR part 113, you must verify and document that the food was produced in accordance with 21 CFR part 113, as required by 21 CFR 1.502(b)(1). However, you did not verify and document that the canned food products you import, including but not limited to (b)(4) Golden Mushroom, imported from (b)(4) located in (b)(4) were produced in accordance with 21 CFR part 113 (regarding thermally processed low-acid foods packaged in hermetically sealed containers), as required by 21 CFR 1.502(b)(1).\nDuring our inspection close-out you provided the following documents:\nHACCP plan containing a hazard analysis, a third-party audit report, and certificate from your foreign supplier (b)(4) located in (b)(4)\nA Certificate of Analysis (COA) and a HACCP certificate from your foreign supplier (b)(4) located in (b)(4); this document identified the US Importer as (b)(4)\nYou stated you obtained these from your import liaisons. However, it is not clear how these documents would apply to your FSVP program, and you did not explain how they would apply to your FSVP program.\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.\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.\nIn 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: Sandra K. Wangen Compliance Officer, Division of West Coast Imports, 934 Broadway, Suite 101, Tacoma, WA 98402; or via email to wcid@fda.hhs.gov, Attention: Sandra K. Wangen, Compliance Officer. If you have any questions regarding this letter, you may contact Sandra K. Wangen via email at sandra.wangen@fda.hhs.gov. Please reference CMS # 736539 on any documents or records you provide to us and\u002F or within the subject line of any email correspondence you send to us.\nSincerely,\n\u002FS\u002F\nDr. Kathleen Turner\nProgram Division Director\nDivision of West Coast Imports","2026-10-14T12:34:32.17+00:00",[23,24,25,9,10,26,26,26],"\u003Ctime datetime=\"2026-09-29T04:00:00Z\">09\u002F29\u002F2026\u003C\u002Ftime>\n","\u003Ctime datetime=\"2026-08-13T04:00:00Z\">08\u002F13\u002F2026\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fbo-wah-enterprises-inc-736539-08132026\">Bo Wah Enterprises Inc\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"]