[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-repare-skincare-680247-07252024":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},1339,"repare-skincare-680247-07252024","Warning Letter","Repare Skincare",null,"Center for Drug Evaluation and Research (CDER)","Finished Pharmaceuticals\u002FUnapproved New Drugs","2024-07-30","2024-07-25","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Frepare-skincare-680247-07252024","680247","Drugs","Via Email","Karen Martin","\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                                                                                                                                                                                                                                                                                                                                                                                                                              \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\">Karen Martin\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n                    \n            \u003Cdd>Repare Skincare\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">16 Spinnaker Drive\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"locality\">Mashpee\u003C\u002Fspan>, \u003Cspan class=\"administrative-area\">MA\u003C\u002Fspan> \u003Cspan class=\"postal-code\">02649-3654\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:info@repareskincare.com\"> info@repareskincare.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=\"MsoNormal text-align-center\">\u003Cstrong>WARNING LETTER\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp class=\"MsoNormal\">July 25, 2024\u003C\u002Fp>\n\n\u003Cp class=\"MsoNormal\">Repare, LLC\u003Cbr>\n177 Fairway Crossing\u003Cbr>\nCrossing, Glastonbury, CT 06033\u003C\u002Fp>\n\n\u003Cp class=\"MsoNormal text-align-center\">RE: 680247\u003C\u002Fp>\n\n\u003Cp class=\"MsoNormal\">Dear Karen Martin:\u003C\u002Fp>\n\n\u003Cp class=\"MsoNormal\">This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website, at the internet address https:\u002F\u002Frepareskincare.com in March 2024 and has observed that your website offers numerous chemical peel drug products; including multiple strengths of Trichloroacetic Acid (TCA) and Glycolic Acid products\u003Csup>\u003Cem>\u003Cstrong>1\u003C\u002Fstrong>\u003C\u002Fem>\u003C\u002Fsup> including “100% TCA Skin Peel” and “GLYCOLIC ACID 70%” (herein referred to as your “TCA chemical peels” and “Glycolic Acid chemical peels”) for sale in the United States. As described below, your TCA chemical peels and Glycolic Acid chemical peels 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).\u003C\u002Fp>\n\n\u003Cp class=\"MsoNormal\">The Agency is concerned about potent chemical peel products that are available to be purchased and used by consumers. Such products pose a public health risk because they can cause skin injuries such as burns on the area of application, wounds, pain, swelling, and scarring. FDA has received adverse event reports of injuries involving use of such products, some of which required emergency room care, specialty care from a dermatologist, and\u002For surgical intervention.\u003C\u002Fp>\n\n\u003Cp class=\"MsoNormal\">\u003Cstrong>Unapproved New Drugs\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp class=\"MsoNormal\">Based on a review of your website, your firm’s TCA chemical peels and Glycolic Acid chemical peels 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 class=\"MsoNormal\">Examples of claims observed on your website that establish evidence of the intended use of these products as drugs include, but may not be limited to, the following (emphasis original):\u003C\u002Fp>\n\n\u003Cp class=\"MsoNormal\">From the webpage https:\u002F\u002Frepareskincare.com\u002Fproducts\u002Ftca-peel:\u003Cbr>\n• “Revitalizing TCA Skin Peel: Customize Your Strength from 15% to 100% - Target Wrinkles, Acne, and Imperfections . . .\u003Cbr>\n  o TCA Skin Peel Kit Uses: Tattoo removal, warts, moles, skin tags, aging, scars”\u003Cbr>\n• “\u003Cstrong>Introducing RePare Skincare’s TCA Skin Peel\u003C\u002Fstrong>\u003Cbr>\n  o Renew aging skin with our DIY at-home skin peel...\u003Cbr>\n  o Reduce fine lines and wrinkles\u003Cbr>\n  o Stimulate collagen production\u003Cbr>\n  o Reveal softer, more youthful skin\u003Cbr>\n  o Visibly fade freckles, scars, and hyperpigmentation”\u003C\u002Fp>\n\n\u003Cp class=\"MsoNormal\">From the webpage https:\u002F\u002Frepareskincare.com:\u003Cbr>\n• “START REBUILDING YOUR COLLAGEN TODAY WITH A TCA PEEL!”\u003Cbr>\n• “\u003Cstrong>TCA & GLYCOLIC PEEL INDICATIONS\u003C\u002Fstrong>: . . .\u003Cbr>\n  o Fine lines, Wrinkles, Crepey Skin\u003Cbr>\n  o Stimulates Collagen & Elastin\u003Cbr>\n  o Hyper-pigmentation \u002F Age Spots \u002F Sun Damage\u003Cbr>\n  o Enlarged Pores, Acne Scars & Stretch Marks\u003Cbr>\n  o Lightens & Brightens\u003Cbr>\n  o Actinic Keratosis\u003Cbr>\n  o Fades Tattoos\u003Cbr>\n  o Skin Tags”\u003C\u002Fp>\n\n\u003Cp class=\"MsoNormal\">From the webpage https:\u002F\u002Frepareskincare.com\u002Fproducts\u002Fglycolic-acid-peel:\u003Cbr>\n• “Versatile Glycolic Acid Peel Range 25%-70% - Professional Formula for Age-Defying Skin . . . removes the outer layer of the epidermis and dermis. Professionally formulated to reduce wrinkles, fine lines, crepey skin, acne, large pores, age spots and hyper-pigmentation. It dramatically reverses the visible signs of aging.”\u003C\u002Fp>\n\n\u003Cp class=\"MsoNormal\">Your TCA chemical peels and Glycolic Acid chemical peels are not generally recognized as safe and effective for the 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 legally introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). 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 class=\"MsoNormal\">\u003Cstrong>Conclusion\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp class=\"MsoNormal\">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 class=\"MsoNormal\">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. Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within fifteen working days, state the reason for the delay and the time within which you will do so. 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.\u003C\u002Fp>\n\n\u003Cp class=\"MsoNormal\">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 class=\"MsoNormal\">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\u003Cp class=\"MsoNormal\">____________________\u003C\u002Fp>\n\n\u003Cp class=\"MsoNormal\">\u003Cem>\u003Cstrong>1\u003C\u002Fstrong>\u003C\u002Fem> We have observed that your website offers TCA Skin Peels in 15%, 20%, 25%, 35%, 50%, and 100% strengths, and Glycolic Acid peel in 25%, 35%, and 70% strengths.\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\nProduct:\n\nDrugs\n\nRecipient:\n\nRecipient Name\n\nKaren Martin\n\nRepare Skincare\n\n16 Spinnaker Drive\n\nMashpee, MA 02649-3654\n\nUnited States\n\ninfo@repareskincare.com\n\nIssuing Office:\n\nCenter for Drug Evaluation and Research (CDER)\n\nUnited States\n\nWARNING LETTER\n\nJuly 25, 2024\n\nRepare, LLC\n\n177 Fairway Crossing\n\nCrossing, Glastonbury, CT 06033\n\nRE: 680247\n\nDear Karen Martin:\n\nThis letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website, at the internet address https:\u002F\u002Frepareskincare.com in March 2024 and has observed that your website offers numerous chemical peel drug products; including multiple strengths of Trichloroacetic Acid (TCA) and Glycolic Acid products1 including “100% TCA Skin Peel” and “GLYCOLIC ACID 70%” (herein referred to as your “TCA chemical peels” and “Glycolic Acid chemical peels”) for sale in the United States. As described below, your TCA chemical peels and Glycolic Acid chemical peels 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).\n\nThe Agency is concerned about potent chemical peel products that are available to be purchased and used by consumers. Such products pose a public health risk because they can cause skin injuries such as burns on the area of application, wounds, pain, swelling, and scarring. FDA has received adverse event reports of injuries involving use of such products, some of which required emergency room care, specialty care from a dermatologist, and\u002For surgical intervention.\n\nUnapproved New Drugs\n\nBased on a review of your website, your firm’s TCA chemical peels and Glycolic Acid chemical peels 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 observed on your website that establish evidence of the intended use of these products as drugs include, but may not be limited to, the following (emphasis original):\n\nFrom the webpage https:\u002F\u002Frepareskincare.com\u002Fproducts\u002Ftca-peel:\n\n• “Revitalizing TCA Skin Peel: Customize Your Strength from 15% to 100% - Target Wrinkles, Acne, and Imperfections . . .\n\no TCA Skin Peel Kit Uses: Tattoo removal, warts, moles, skin tags, aging, scars”\n\n• “Introducing RePare Skincare’s TCA Skin Peel\n\no Renew aging skin with our DIY at-home skin peel...\n\no Reduce fine lines and wrinkles\n\no Stimulate collagen production\n\no Reveal softer, more youthful skin\n\no Visibly fade freckles, scars, and hyperpigmentation”\n\nFrom the webpage https:\u002F\u002Frepareskincare.com:\n\n• “START REBUILDING YOUR COLLAGEN TODAY WITH A TCA PEEL!”\n\n• “TCA & GLYCOLIC PEEL INDICATIONS: . . .\n\no Fine lines, Wrinkles, Crepey Skin\n\no Stimulates Collagen & Elastin\n\no Hyper-pigmentation \u002F Age Spots \u002F Sun Damage\n\no Enlarged Pores, Acne Scars & Stretch Marks\n\no Lightens & Brightens\n\no Actinic Keratosis\n\no Fades Tattoos\n\no Skin Tags”\n\nFrom the webpage https:\u002F\u002Frepareskincare.com\u002Fproducts\u002Fglycolic-acid-peel:\n\n• “Versatile Glycolic Acid Peel Range 25%-70% - Professional Formula for Age-Defying Skin . . . removes the outer layer of the epidermis and dermis. Professionally formulated to reduce wrinkles, fine lines, crepey skin, acne, large pores, age spots and hyper-pigmentation. It dramatically reverses the visible signs of aging.”\n\nYour TCA chemical peels and Glycolic Acid chemical peels are not generally recognized as safe and effective for the 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 legally introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). 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. Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within fifteen working days, state the reason for the delay and the time within which you will do so. 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.\n\nYour 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\n\n____________________\n\n1 We have observed that your website offers TCA Skin Peels in 15%, 20%, 25%, 35%, 50%, and 100% strengths, and Glycolic Acid peel in 25%, 35%, and 70% strengths.","2026-08-19T23:55:39.769+00:00",[23,24,25,9,10,26,26,26],"\u003Ctime datetime=\"2024-07-30T13:20:00Z\">07\u002F30\u002F2024\u003C\u002Ftime>\n","\u003Ctime datetime=\"2024-07-25T04:00:00Z\">07\u002F25\u002F2024\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Frepare-skincare-680247-07252024\">Repare Skincare\u003C\u002Fa>","","2026-08-18T06:42:28.856152+00:00","2026-08-20T02:24:56.037289+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"]