[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-premier-manufacturing-products-llc-678912-07022024":3,"fda-latest-sync-dates":28},{"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":11,"response_letter_date":8,"closeout_date":8,"case_status":12,"letter_url":13,"reference_number":8,"marcs_cms_no":14,"product_type":15,"delivery_method":16,"recipient_name":17,"recipient_title":8,"body_html":18,"body_text":19,"body_fetched_at":20,"medical_device_id":8,"raw":21,"created_at":26,"updated_at":27},1396,"premier-manufacturing-products-llc-678912-07022024","Warning Letter","Premier Manufacturing Products, LLC",null,"Center for Drug Evaluation and Research | CDER","Finished Pharmaceuticals\u002FUnapproved New Drug","2024-07-02","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fpremier-manufacturing-products-llc-678912-07022024","678912","Drugs","Via Email Atofil@mtdst.us","James P. Morrissette","\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                                                                                                                                                                                                                                                                                                                                                                                      \u003Cbr>Atofil@mtdst.us\n                                                                          \u003C\u002Fdd>\n      \n      \n              \u003Cdt class=\"cell-1_3\">Product:\u003C\u002Fdt> \n        \u003Cdd class=\"cell-2_3\">Drugs                          \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\">James P. Morrissette\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\">CEO\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n          \n            \u003Cdd>Premier Manufacturing Products, LLC\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">912 46th Lane Unit 204\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"locality\">Cape Coral\u003C\u002Fspan>, \u003Cspan class=\"administrative-area\">FL\u003C\u002Fspan> \u003Cspan class=\"postal-code\">33904\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:JPM@premiermt.com\"> JPM@premiermt.com\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>Center for Drug Evaluation and Research | CDER\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>July 2, 2024\u003Cbr>\n\u003Cbr>\nChristopher Mitchell, COO\u003Cbr>\nIT@MTDST.US\u003Cbr>\nCSM@premierMT.com\u003C\u002Fp>\n\n\u003Cp>Deborah L. Lloyd\u003Cbr>\nPremier Manufacturing Products, LLC\u003Cbr>\n730 NE 19th Place,\u003Cbr>\nCape Coral, FL 33909\u003Cbr>\nDlloyd@atofil.us\u003C\u002Fp>\n\n\u003Cp class=\"text-align-center\">\u003Cstrong>RE: 678912\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp>Dear James Morrissette, Christopher Mitchell and Deborah Lloyd:\u003C\u002Fp>\n\n\u003Cp>This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed labeling obtained from an inspection of your drug manufacturing facility, Atofil, LLC, from January 22 to 25, 2024, from which FDA observed that you offer numerous Tianeptine products, specifically “Tianaa Red,” “Tianaa White,” and “Tianaa Green” for sale in the United States. Based on our review, your “Tianaa Red,” “Tianaa White,” and “Tianaa Green” products are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d). As explained further below, introducing or delivering these products for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).\u003C\u002Fp>\n\n\u003Cp>\u003Cstrong>Unapproved New Drugs\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp>Based on our review of the product labeling obtained during the inspection, your “Tianaa Red,” “Tianaa White,” and “Tianaa Green” products are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and\u002For intended to affect the structure or any function of the body.\u003C\u002Fp>\n\n\u003Cp>Examples of claims from your email blast promotional material, which links back to your website https:\u002F\u002Fmtbrands.com\u002Ftianaa, that provide evidence of the intended use of these products as drugs include, but may not be limited to, the following:\u003C\u002Fp>\n\n\u003Cul>\n\t\u003Cli>“The Wait For Tianaa is Over . . . LET US TAKE YOU THERE . . . Tianaa is a proprietary blend of Natural Herbs and Nootropics created to deliver the unparalleled pick up, clarity, relaxation, and relief”\u003C\u002Fli>\n\u003C\u002Ful>\n\n\u003Cp>Your “Tianaa Red,” “Tianaa White,” and “Tianaa Green” products are not generally recognized as safe and effective (GRASE) for their above referenced uses and, therefore, are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). Subject to certain exceptions not applicable here, new drugs may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d). No FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for these products. Accordingly, the introduction or delivery for introduction into interstate commerce of these products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).\u003C\u002Fp>\n\n\u003Cp>\u003Cstrong>Conclusion\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp>This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.\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 legal action including, without limitation, seizure and injunction.\u003C\u002Fp>\n\n\u003Cp>Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct these violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. Your response should be sent to U.S. Food and Drug Administration, CDER\u002FOC\u002FOffice of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov.\u003C\u002Fp>\n\n\u003Cp>Sincerely,\u003Cbr>\n\u002FS\u002F\u003Cbr>\nTina Smith, M.S.\u003Cbr>\nCaptain, U.S Public Health Service\u003Cbr>\nDirector\u003Cbr>\nOffice of Unapproved Drugs and Labeling Compliance\u003Cbr>\nOffice of Compliance\u003Cbr>\nCenter for Drug Evaluation and Research\u003Cbr>\nFood and Drug Administration\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\n\nAtofil@mtdst.us\n\nProduct:\n\nDrugs\n\nRecipient:\n\nRecipient Name\n\nJames P. Morrissette\n\nRecipient Title\n\nCEO\n\nPremier Manufacturing Products, LLC\n\n912 46th Lane Unit 204\n\nCape Coral, FL 33904\n\nUnited States\n\nJPM@premiermt.com\n\nIssuing Office:\n\nCenter for Drug Evaluation and Research | CDER\n\nUnited States\n\nWARNING LETTER\n\nJuly 2, 2024\n\nChristopher Mitchell, COO\n\nIT@MTDST.US\n\nCSM@premierMT.com\n\nDeborah L. Lloyd\n\nPremier Manufacturing Products, LLC\n\n730 NE 19th Place,\n\nCape Coral, FL 33909\n\nDlloyd@atofil.us\n\nRE: 678912\n\nDear James Morrissette, Christopher Mitchell and Deborah Lloyd:\n\nThis letter is to advise you that the United States Food and Drug Administration (FDA) reviewed labeling obtained from an inspection of your drug manufacturing facility, Atofil, LLC, from January 22 to 25, 2024, from which FDA observed that you offer numerous Tianeptine products, specifically “Tianaa Red,” “Tianaa White,” and “Tianaa Green” for sale in the United States. Based on our review, your “Tianaa Red,” “Tianaa White,” and “Tianaa Green” products are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d). As explained further below, introducing or delivering these products for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).\n\nUnapproved New Drugs\n\nBased on our review of the product labeling obtained during the inspection, your “Tianaa Red,” “Tianaa White,” and “Tianaa Green” products are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and\u002For intended to affect the structure or any function of the body.\n\nExamples of claims from your email blast promotional material, which links back to your website https:\u002F\u002Fmtbrands.com\u002Ftianaa, that provide evidence of the intended use of these products as drugs include, but may not be limited to, the following:\n\n“The Wait For Tianaa is Over . . . LET US TAKE YOU THERE . . . Tianaa is a proprietary blend of Natural Herbs and Nootropics created to deliver the unparalleled pick up, clarity, relaxation, and relief”\n\nYour “Tianaa Red,” “Tianaa White,” and “Tianaa Green” products are not generally recognized as safe and effective (GRASE) for their above referenced uses and, therefore, are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). Subject to certain exceptions not applicable here, new drugs may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d). No FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for these products. Accordingly, the introduction or delivery for introduction into interstate commerce of these products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).\n\nConclusion\n\nThis letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.\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 legal action including, without limitation, seizure and injunction.\n\nPlease notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct these violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. Your response should be sent to U.S. Food and Drug Administration, CDER\u002FOC\u002FOffice of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov.\n\nSincerely,\n\n\u002FS\u002F\n\nTina Smith, M.S.\n\nCaptain, U.S Public Health Service\n\nDirector\n\nOffice of Unapproved Drugs and Labeling Compliance\n\nOffice of Compliance\n\nCenter for Drug Evaluation and Research\n\nFood and Drug Administration","2026-08-20T00:00:07.13+00:00",[22,23,24,9,10,25,25,25],"\u003Ctime datetime=\"2024-07-02T13:20:00Z\">07\u002F02\u002F2024\u003C\u002Ftime>\n","\u003Ctime datetime=\"2024-07-02T04:00:00Z\">07\u002F02\u002F2024\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fpremier-manufacturing-products-llc-678912-07022024\">Premier Manufacturing Products, LLC\u003C\u002Fa>","","2026-08-18T06:42:28.856152+00:00","2026-08-20T02:24:56.037289+00:00",{"510k":29,"classification":30,"enforcement":31,"event":32,"pma":33,"warning_letter":34},"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"]