[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-2m-associates-inc-614195-07202021":3,"fda-latest-sync-dates":31},{"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":13,"case_status":14,"letter_url":15,"reference_number":8,"marcs_cms_no":16,"product_type":17,"delivery_method":18,"recipient_name":19,"recipient_title":8,"body_html":20,"body_text":21,"body_fetched_at":22,"medical_device_id":8,"raw":23,"created_at":29,"updated_at":30},3233,"2m-associates-inc-614195-07202021","Warning Letter","2m Associates, Inc.",null,"Division of Northeast Imports","Foreign Supplier Verification Program (FSVP)","2021-08-03","2021-07-20","2022-04-19","Closed Out","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002F2m-associates-inc-614195-07202021","614195","Food & Beverages","VIA UNITED PARCEL SERVICE","Mr. Alpha Bah","\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 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\">Mr. Alpha Bah\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\">C.E.O. and Owner\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n          \n            \u003Cdd>2m Associates, Inc.\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">203 W. 140th St, Apt. 4C\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"locality\">New York\u003C\u002Fspan>, \u003Cspan class=\"administrative-area\">NY\u003C\u002Fspan> \u003Cspan class=\"postal-code\">10030\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\u003Cbr>\nCMS # 614195\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp>Date: 7\u002F20\u002F2021\u003C\u002Fp>\n\n\u003Cp>Dear Mr. Bah:\u003C\u002Fp>\n\n\u003Cp>On February 1, 2021 through March 3, 2021, the Food and Drug Administration (FDA) conducted a remote Foreign Supplier Verification Program (FSVP) inspection of 2m Associates Inc. located at 523 Casanova Street, Bronx, NY 10474. We also conducted an initial inspection on April 12, 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.\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 inspection, we found that you were not in compliance with the requirements of 21 CFR part 1 subpart L for your \u003Cstrong>(b)(4)\u003C\u002Fstrong> broken rice and \u003Cstrong>(b)(4) \u003C\u002Fstrong>rice imported from \u003Cstrong>(b)(4)\u003C\u002Fstrong>, located in \u003Cstrong>(b)(4)\u003C\u002Fstrong>. Your firm did not have FSVPs for these foods. Because of this significant violation, 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>As of the date of this letter, we have not received your response to the Form FDA 483a issued on March 3, 2021.\u003C\u002Fp>\n\n\u003Cp>Your significant violation of the FSVP regulation is 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 each of the following foods:\u003Cbr>\n• \u003Cstrong>(b)(4)\u003C\u002Fstrong> broken rice imported from \u003Cstrong>(b)(4)\u003C\u002Fstrong>, located in \u003Cstrong>(b)(4)\u003C\u002Fstrong>.\u003Cbr>\n• \u003Cstrong>(b)(4)\u003C\u002Fstrong> rice imported from \u003Cstrong>(b)(4)\u003C\u002Fstrong>, located in \u003Cstrong>(b)(4)\u003C\u002Fstrong>.\u003C\u002Fp>\n\n\u003Cp>The above is 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. Failure to adequately address this matter may result in 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 \u003Cstrong>(b)(4)\u003C\u002Fstrong> broken rice and \u003Cstrong>(b)(4)\u003C\u002Fstrong> rice imported from \u003Cstrong>(b)(4)\u003C\u002Fstrong>, located in \u003Cstrong>(b)(4)\u003C\u002Fstrong>. We may place the food you import from the identified foreign supplier 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=\"http:\u002F\u002Fwww.accessdata.fda.gov\u002Fcms_ia\u002Fialist.html\">http:\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.\u003C\u002Fp>\n\n\u003Cp>You should respond in writing to the FSVP violations 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 will 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: Linda Ross, FDA Compliance Officer; Division of Northeast Imports: ORAOEIONEIMPORTSWLResponses@fda.hhs.gov. Please also cc (carbon copy) linda.ross@fda.hhs.gov. If you have any questions regarding this letter, you may contact Compliance Officer Ross via email at linda.ross@fda.hhs.gov. Please reference CMS # 614195 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>Dawne Hines\u003Cbr>\nProgram 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 UNITED PARCEL SERVICE\n\nProduct:\n\nFood & Beverages\n\nRecipient:\n\nRecipient Name\n\nMr. Alpha Bah\n\nRecipient Title\n\nC.E.O. and Owner\n\n2m Associates, Inc.\n\n203 W. 140th St, Apt. 4C\n\nNew York, NY 10030\n\nUnited States\n\nIssuing Office:\n\nDivision of Northeast Imports\n\nUnited States\n\nWARNING LETTER\n\nCMS # 614195\n\nDate: 7\u002F20\u002F2021\n\nDear Mr. Bah:\n\nOn February 1, 2021 through March 3, 2021, the Food and Drug Administration (FDA) conducted a remote Foreign Supplier Verification Program (FSVP) inspection of 2m Associates Inc. located at 523 Casanova Street, Bronx, NY 10474. We also conducted an initial inspection on April 12, 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 inspection, we found that you were not in compliance with the requirements of 21 CFR part 1 subpart L for your (b)(4) broken rice and (b)(4) rice imported from (b)(4), located in (b)(4). Your firm did not have FSVPs for these foods. Because of this significant violation, 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\nAs of the date of this letter, we have not received your response to the Form FDA 483a issued on March 3, 2021.\n\nYour significant violation of the FSVP regulation is 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 each of the following foods:\n\n• (b)(4) broken rice imported from (b)(4), located in (b)(4).\n\n• (b)(4) rice imported from (b)(4), located in (b)(4).\n\nThe above is 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. Failure to adequately address this matter may result in 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 (b)(4) broken rice and (b)(4) rice imported from (b)(4), located in (b)(4). We may place the food you import from the identified foreign supplier 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.\n\nYou should respond in writing to the FSVP violations 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 will 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: Linda Ross, FDA Compliance Officer; Division of Northeast Imports: ORAOEIONEIMPORTSWLResponses@fda.hhs.gov. Please also cc (carbon copy) linda.ross@fda.hhs.gov. If you have any questions regarding this letter, you may contact Compliance Officer Ross via email at linda.ross@fda.hhs.gov. Please reference CMS # 614195 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\nDawne Hines\n\nProgram Division Director\n\nDivision of Northeast Imports","2026-08-20T02:43:53.314+00:00",[24,25,26,9,10,27,28,27],"\u003Ctime datetime=\"2021-08-03T13:20:00Z\">08\u002F03\u002F2021\u003C\u002Ftime>\n","\u003Ctime datetime=\"2021-07-20T04:00:00Z\">07\u002F20\u002F2021\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002F2m-associates-inc-614195-07202021\">2m Associates, Inc.\u003C\u002Fa>","","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002F2m-associates-inc-614195-04122022\">\u003Ctime datetime=\"2022-04-19T04:00:00Z\">04\u002F19\u002F2022\u003C\u002Ftime>\n\u003C\u002Fa>","2026-08-18T06:42:29.386127+00:00","2026-08-20T02:43:55.443323+00:00",{"510k":32,"classification":33,"enforcement":34,"event":35,"pma":36,"warning_letter":37},"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"]