[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-guangzhou-orchard-aromatherapy-skin-care-co-ltd-628678-07202022":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},2553,"guangzhou-orchard-aromatherapy-skin-care-co-ltd-628678-07202022","Warning Letter","Guangzhou Orchard Aromatherapy & Skin Care Co., Ltd.",null,"Center for Drug Evaluation and Research | CDER","Refusal to Provide Access to and Copying of Records","2022-07-26","2022-07-20","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fguangzhou-orchard-aromatherapy-skin-care-co-ltd-628678-07202022","628678","Drugs","VIA UPS","Ms. Zhifang Jiang","\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 UPS\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\">Ms. Zhifang Jiang\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n                    \n            \u003Cdd>Guangzhou Orchard Aromatherapy & Skin Care Co., Ltd.\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">No.38 Liansheng Industrial Pack\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"address-line2\">Hongqi Village, Qinghong Road\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"locality\">Guangzhou Shi\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"administrative-area\">Guangdong Sheng\u003C\u002Fspan>, \u003Cspan class=\"postal-code\">510545\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"country\">China\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>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> 320-22-21\u003C\u002Fp>\n\n\u003Cp>July 20, 2022\u003C\u002Fp>\n\n\u003Cp>Dear Ms. Zhifang Jiang:\u003C\u002Fp>\n\n\u003Cp>Your firm is registered with the United States Food and Drug Administration (FDA or Agency) as a manufacturer of over-the-counter (OTC) drug products including hand sanitizers, specifically, Orchard de Flore INSTANT HAND SANITIZER and artnaturals HAND SANITIZER. A review of import records showed multiple shipments of OTC drug products into the U.S. which declared Guangzhou Orchard Aromatherapy & Skin Care Co., Ltd. as the drug manufacturer. On August 9, 2021, the FDA sent an electronic request for records and other information pursuant to section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 374(a)(4), to the contact e-mail address provided in your registration file. This request went unanswered. A second request was sent via e-mail on August 27, 2021, followed by a telephone conversation with your registered U.S. Agent on October 26, 2021, regarding this matter. The Agency sent a follow-up written request for such records and other information on November 24, 2021. Delivery to you was confirmed by the shipper, but you failed to respond to these attempted communications or otherwise provide the requested records or other information. Pursuant to section 704(a)(4), FDA’s request and follow-up communication included a sufficient and clear description of the records sought.\u003C\u002Fp>\n\n\u003Cp>It is a prohibited act under section 301(e) of the FD&C Act (21 U.S.C. 331(e)) to refuse to permit access to or copying of any record as required by section 704(a).\u003C\u002Fp>\n\n\u003Cp>Since the declaration of the COVID-19 public health emergency,\u003Csup>\u003Cem>\u003Cstrong>1\u003C\u002Fstrong>\u003C\u002Fem>\u003C\u002Fsup> a number of hand sanitizer drug products have been recalled due to quality issues ranging from substitution with other drug substances to subpotency.\u003Csup>\u003Cem>\u003Cstrong>2\u003C\u002Fstrong>\u003C\u002Fem>\u003C\u002Fsup> The Agency has reached out to registered OTC drug firms with hand sanitizers drug products included in their product listing to assess the overall quality of the drugs registered as manufactured by these firms. Because your OTC drug firm failed to respond to the section 704(a)(4) records requests and associated communication attempts, we have no indication of the level of quality assurance for drugs registered as manufactured at your facility.\u003C\u002Fp>\n\n\u003Cp>FDA placed all drugs and drug products manufactured by your firm on Import Alert 66-79 on May 16, 2022.\u003C\u002Fp>\n\n\u003Cp>Until FDA is able to confirm compliance with CGMP and other applicable requirements, we may withhold approval of any new applications or supplements listing your firm as a drug manufacturer. In addition, shipments of articles manufactured at Guangzhou Orchard Aromatherapy & Skin Care Co., Ltd., No. 38 Liansheng Industrial Pack, Hongqi Village, Qinghong Road, Guangzhou, Guangdong into the United States that appear to be adulterated or misbranded are subject to being detained or refused admission pursuant to section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3).\u003C\u002Fp>\n\n\u003Cp>On June 8, 2022, FDA notified the public at the following website that you failed to respond to multiple FDA requests for records related to drug manufacturing and product quality, and that drugs and drug products from your facility had been added to Import Alert 66-79 on May 16, 2022, to urge consumers not to use your hand sanitizer drug products at the following website: \u003Ca href=\"https:\u002F\u002Fwww.fda.gov\u002Fdrugs\u002Fdrug-safety-and-availability\u002Ffda-updates-hand-sanitizers-consumers-should-not-use\">https:\u002F\u002Fwww.fda.gov\u002Fdrugs\u002Fdrug-safety-and-availability\u002Ffda-updates-hand-sanitizers-consumers-should-not-use\u003C\u002Fa>\u003C\u002Fp>\n\n\u003Cp>After you receive this letter, respond to this office in writing within 15 working days. In response to this letter, you may provide information for our consideration as we continue to assess your activities and practices, and\u002For submit a request to schedule an FDA inspection.\u003Cbr>\nSend your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3012368173 and ATTN: Christina Capacci-Daniel.\u003C\u002Fp>\n\n\u003Cp>Sincerely,\u003Cbr>\n\u002FS\u002F\u003Cbr>\nFrancis Godwin\u003Cbr>\nDirector\u003Cbr>\nOffice of Manufacturing Quality\u003Cbr>\nOffice of Compliance\u003Cbr>\nCenter for Drug Evaluation and Research, FDA\u003C\u002Fp>\n\n\u003Cp>CC:\u003Cbr>\nRegistered U.S. Agent:\u003Cbr>\nDavid Lennarz\u003Cbr>\nRegistrar Corp\u003Cbr>\n144 Research Drive\u003Cbr>\nHampton, VA, 23666\u003Cbr>\n757-224-0177\u003Cbr>\ndrugs@registrarcorp.com\u003C\u002Fp>\n\n\u003Cp>CC:\u003Cbr>\nMr. Yosef Nourollah\u003Cbr>\nCEO\u003Cbr>\nVirgin Scent, Inc. \u003Cem>dba\u003C\u002Fem> Artnaturals\u003Cbr>\n2390 Crenshaw Blvd, PMB #702\u003Cbr>\nTorrance, CA 90501\u003C\u002Fp>\n\n\u003Cp>_______________________\u003C\u002Fp>\n\n\u003Cp>\u003Cem>\u003Cstrong>1\u003C\u002Fstrong>\u003C\u002Fem> The HHS Declaration of a Public Health Emergency is available at \u003Ca href=\"https:\u002F\u002Fwww.phe.gov\u002Femergency\u002Fnews\u002Fhealthactions\u002Fphe\u002FPages\u002F2019-nCoV.aspx\">https:\u002F\u002Fwww.phe.gov\u002Femergency\u002Fnews\u002Fhealthactions\u002Fphe\u002FPages\u002F2019-nCoV.aspx\u003C\u002Fa>.\u003C\u002Fp>\n\n\u003Cp>\u003Cem>\u003Cstrong>2\u003C\u002Fstrong>\u003C\u002Fem> In March 2020, the Agency published three guidance documents to provide regulatory flexibility to certain firms to help meet the demand for alcohol-based hand sanitizer during the COVID-19 public health emergency (PHE). Additionally, on December 31, 2021 these guidances were withdrawn, and firms were required to cease distribution, by March 31, 2022, of any remaining hand sanitizer products that were prepared under the temporary policies before or on December 31, 2021. See, 86 FR 56960, October 13, 2021.\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 UPS\n\nProduct:\n\nDrugs\n\nRecipient:\n\nRecipient Name\n\nMs. Zhifang Jiang\n\nGuangzhou Orchard Aromatherapy & Skin Care Co., Ltd.\n\nNo.38 Liansheng Industrial Pack\n\nHongqi Village, Qinghong Road\n\nGuangzhou Shi\n\nGuangdong Sheng, 510545\n\nChina\n\nIssuing Office:\n\nCenter for Drug Evaluation and Research | CDER\n\nUnited States\n\nWarning Letter 320-22-21\n\nJuly 20, 2022\n\nDear Ms. Zhifang Jiang:\n\nYour firm is registered with the United States Food and Drug Administration (FDA or Agency) as a manufacturer of over-the-counter (OTC) drug products including hand sanitizers, specifically, Orchard de Flore INSTANT HAND SANITIZER and artnaturals HAND SANITIZER. A review of import records showed multiple shipments of OTC drug products into the U.S. which declared Guangzhou Orchard Aromatherapy & Skin Care Co., Ltd. as the drug manufacturer. On August 9, 2021, the FDA sent an electronic request for records and other information pursuant to section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 374(a)(4), to the contact e-mail address provided in your registration file. This request went unanswered. A second request was sent via e-mail on August 27, 2021, followed by a telephone conversation with your registered U.S. Agent on October 26, 2021, regarding this matter. The Agency sent a follow-up written request for such records and other information on November 24, 2021. Delivery to you was confirmed by the shipper, but you failed to respond to these attempted communications or otherwise provide the requested records or other information. Pursuant to section 704(a)(4), FDA’s request and follow-up communication included a sufficient and clear description of the records sought.\n\nIt is a prohibited act under section 301(e) of the FD&C Act (21 U.S.C. 331(e)) to refuse to permit access to or copying of any record as required by section 704(a).\n\nSince the declaration of the COVID-19 public health emergency,1 a number of hand sanitizer drug products have been recalled due to quality issues ranging from substitution with other drug substances to subpotency.2 The Agency has reached out to registered OTC drug firms with hand sanitizers drug products included in their product listing to assess the overall quality of the drugs registered as manufactured by these firms. Because your OTC drug firm failed to respond to the section 704(a)(4) records requests and associated communication attempts, we have no indication of the level of quality assurance for drugs registered as manufactured at your facility.\n\nFDA placed all drugs and drug products manufactured by your firm on Import Alert 66-79 on May 16, 2022.\n\nUntil FDA is able to confirm compliance with CGMP and other applicable requirements, we may withhold approval of any new applications or supplements listing your firm as a drug manufacturer. In addition, shipments of articles manufactured at Guangzhou Orchard Aromatherapy & Skin Care Co., Ltd., No. 38 Liansheng Industrial Pack, Hongqi Village, Qinghong Road, Guangzhou, Guangdong into the United States that appear to be adulterated or misbranded are subject to being detained or refused admission pursuant to section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3).\n\nOn June 8, 2022, FDA notified the public at the following website that you failed to respond to multiple FDA requests for records related to drug manufacturing and product quality, and that drugs and drug products from your facility had been added to Import Alert 66-79 on May 16, 2022, to urge consumers not to use your hand sanitizer drug products at the following website: https:\u002F\u002Fwww.fda.gov\u002Fdrugs\u002Fdrug-safety-and-availability\u002Ffda-updates-hand-sanitizers-consumers-should-not-use\n\nAfter you receive this letter, respond to this office in writing within 15 working days. In response to this letter, you may provide information for our consideration as we continue to assess your activities and practices, and\u002For submit a request to schedule an FDA inspection.\n\nSend your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3012368173 and ATTN: Christina Capacci-Daniel.\n\nSincerely,\n\n\u002FS\u002F\n\nFrancis Godwin\n\nDirector\n\nOffice of Manufacturing Quality\n\nOffice of Compliance\n\nCenter for Drug Evaluation and Research, FDA\n\nCC:\n\nRegistered U.S. Agent:\n\nDavid Lennarz\n\nRegistrar Corp\n\n144 Research Drive\n\nHampton, VA, 23666\n\n757-224-0177\n\ndrugs@registrarcorp.com\n\nCC:\n\nMr. Yosef Nourollah\n\nCEO\n\nVirgin Scent, Inc. dba Artnaturals\n\n2390 Crenshaw Blvd, PMB #702\n\nTorrance, CA 90501\n\n_______________________\n\n1 The HHS Declaration of a Public Health Emergency is available at https:\u002F\u002Fwww.phe.gov\u002Femergency\u002Fnews\u002Fhealthactions\u002Fphe\u002FPages\u002F2019-nCoV.aspx.\n\n2 In March 2020, the Agency published three guidance documents to provide regulatory flexibility to certain firms to help meet the demand for alcohol-based hand sanitizer during the COVID-19 public health emergency (PHE). Additionally, on December 31, 2021 these guidances were withdrawn, and firms were required to cease distribution, by March 31, 2022, of any remaining hand sanitizer products that were prepared under the temporary policies before or on December 31, 2021. See, 86 FR 56960, October 13, 2021.","2026-08-20T01:44:05.134+00:00",[23,24,25,9,10,26,26,26],"\u003Ctime datetime=\"2022-07-26T13:20:00Z\">07\u002F26\u002F2022\u003C\u002Ftime>\n","\u003Ctime datetime=\"2022-07-20T04:00:00Z\">07\u002F20\u002F2022\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fguangzhou-orchard-aromatherapy-skin-care-co-ltd-628678-07202022\">Guangzhou Orchard Aromatherapy & Skin Care Co., Ltd.\u003C\u002Fa>","","2026-08-18T06:42:29.262718+00:00","2026-08-20T02:24:56.48659+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"]