[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-glicerinas-industriales-sa-de-cv-633340-06132022":3,"fda-latest-sync-dates":30},{"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":28,"updated_at":29},2620,"glicerinas-industriales-sa-de-cv-633340-06132022","Warning Letter","Glicerinas Industriales, S.A. de C.V.",null,"Center for Drug Evaluation and Research | CDER","CGMP\u002FFinished Drug Products\u002FRefusal\u002FLimited Inspection","2022-06-21","2022-06-13","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fglicerinas-industriales-sa-de-cv-633340-06132022","633340","Drugs","VIA UPS","Mr. Alfredo Moran Sanchez","\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\">Mr. Alfredo Moran Sanchez\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\">Director\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n          \n            \u003Cdd>Glicerinas Industriales, S.A. de C.V.\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">Calle Uranio No. 80\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"dependent-locality\">Col. Arenales Tapatios\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"postal-code\">45188\u003C\u002Fspan> \u003Cspan class=\"locality\">Zapopan\u003C\u002Fspan>, \u003Cspan class=\"administrative-area\">Jal.\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"country\">Mexico\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 320-22-15\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp>June 13, 2022\u003C\u002Fp>\n\n\u003Cp>Dear Mr. Sanchez:\u003C\u002Fp>\n\n\u003Cp>The U.S. Food and Drug Administration (FDA) notified your site, Glicerinas Industriales, S.A. de C.V. (“GLINSA”), FEI 3016420687, at Calle Uranio No. 80, Col. Arenales Tapatios, Zapopan, of a planned inspection of your drug manufacturing facility from May 16 to May 20, 2022. Your firm refused the pre-announced inspection during a phone call with representatives from the Office of Regulatory Affairs on February 24, 2022, and written notification received by your firm via United Parcel Service (UPS) on March 23, 2022.\u003C\u002Fp>\n\n\u003Cp>Your firm is a supplier of drug components (e.g., glycerin) to manufacturers of finished drug products distributing to the U.S. market. The use of glycerin contaminated with diethylene glycol (DEG) has resulted in various lethal poisoning incidents in humans worldwide.\u003C\u002Fp>\n\n\u003Cp>See FDA’s guidance document Testing of Glycerin for Diethylene Glycol for FDA’s current thinking regarding current good manufacturing practice (CGMP) requirements when manufacturing drugs containing glycerin at \u003Ca href=\"https:\u002F\u002Fwww.fda.gov\u002Fmedia\u002F71029\u002Fdownload\">https:\u002F\u002Fwww.fda.gov\u002Fmedia\u002F71029\u002Fdownload\u003C\u002Fa>.\u003C\u002Fp>\n\n\u003Cp>Under section 501(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(j), your drugs are adulterated in that they have been manufactured, processed, packed, or held in an establishment that delays, denies, or limits an inspection, or refuses to permit entry or inspection.\u003C\u002Fp>\n\n\u003Cp>See FDA’s guidance document, Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection, at \u003Ca href=\"https:\u002F\u002Fwww.fda.gov\u002Fdownloads\u002Fregulatoryinformation\u002Fguidances\u002Fucm360484.pdf\">https:\u002F\u002Fwww.fda.gov\u002Fdownloads\u002Fregulatoryinformation\u002Fguidances\u002Fucm360484.pdf\u003C\u002Fa>.\u003C\u002Fp>\n\n\u003Cp>FDA placed your firm on Import Alert 66-79 on June 9, 2022.\u003C\u002Fp>\n\n\u003Cp>Until FDA is permitted to inspect your facility and confirms compliance with CGMP, we may withhold approval of any new applications or supplements listing your firm as a drug manufacturer. In addition, shipments of articles manufactured at Glicerinas Industriales, S.A. de C.V., Calle Uranio No. 80, Col. Arenales Tapatios, Zapopan, into the United States that appear to be adulterated 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>After you receive this letter, respond to this office in writing within 15 working days. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices, and\u002For submit a request to schedule an FDA inspection.\u003C\u002Fp>\n\n\u003Cp>Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3016420687 and ATTN: Bill Fowler.\u003C\u002Fp>\n\n\u003Cp>Sincerely,\u003Cbr>\n\u002FS\u002F\u003C\u002Fp>\n\n\u003Cp>Francis Godwin\u003Cbr>\nDirector\u003Cbr>\nOffice of Manufacturing Quality\u003Cbr>\nOffice of Compliance\u003Cbr>\nCenter for Drug Evaluation and Research\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\nMr. Alfredo Moran Sanchez\n\nRecipient Title\n\nDirector\n\nGlicerinas Industriales, S.A. de C.V.\n\nCalle Uranio No. 80\n\nCol. Arenales Tapatios\n\n45188 Zapopan, Jal.\n\nMexico\n\nIssuing Office:\n\nCenter for Drug Evaluation and Research | CDER\n\nUnited States\n\nWarning Letter 320-22-15\n\nJune 13, 2022\n\nDear Mr. Sanchez:\n\nThe U.S. Food and Drug Administration (FDA) notified your site, Glicerinas Industriales, S.A. de C.V. (“GLINSA”), FEI 3016420687, at Calle Uranio No. 80, Col. Arenales Tapatios, Zapopan, of a planned inspection of your drug manufacturing facility from May 16 to May 20, 2022. Your firm refused the pre-announced inspection during a phone call with representatives from the Office of Regulatory Affairs on February 24, 2022, and written notification received by your firm via United Parcel Service (UPS) on March 23, 2022.\n\nYour firm is a supplier of drug components (e.g., glycerin) to manufacturers of finished drug products distributing to the U.S. market. The use of glycerin contaminated with diethylene glycol (DEG) has resulted in various lethal poisoning incidents in humans worldwide.\n\nSee FDA’s guidance document Testing of Glycerin for Diethylene Glycol for FDA’s current thinking regarding current good manufacturing practice (CGMP) requirements when manufacturing drugs containing glycerin at https:\u002F\u002Fwww.fda.gov\u002Fmedia\u002F71029\u002Fdownload.\n\nUnder section 501(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(j), your drugs are adulterated in that they have been manufactured, processed, packed, or held in an establishment that delays, denies, or limits an inspection, or refuses to permit entry or inspection.\n\nSee FDA’s guidance document, Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection, at https:\u002F\u002Fwww.fda.gov\u002Fdownloads\u002Fregulatoryinformation\u002Fguidances\u002Fucm360484.pdf.\n\nFDA placed your firm on Import Alert 66-79 on June 9, 2022.\n\nUntil FDA is permitted to inspect your facility and confirms compliance with CGMP, we may withhold approval of any new applications or supplements listing your firm as a drug manufacturer. In addition, shipments of articles manufactured at Glicerinas Industriales, S.A. de C.V., Calle Uranio No. 80, Col. Arenales Tapatios, Zapopan, into the United States that appear to be adulterated 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\nAfter you receive this letter, respond to this office in writing within 15 working days. In response to this letter, you may provide additional 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 3016420687 and ATTN: Bill Fowler.\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","2026-08-20T01:49:50.573+00:00",[23,24,25,9,26,27,27,27],"\u003Ctime datetime=\"2022-06-21T13:20:00Z\">06\u002F21\u002F2022\u003C\u002Ftime>\n","\u003Ctime datetime=\"2022-06-13T04:00:00Z\">06\u002F13\u002F2022\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fglicerinas-industriales-sa-de-cv-633340-06132022\">Glicerinas Industriales, S.A. de C.V.\u003C\u002Fa>","CGMP\u002FFinished Drug Products\u002FRefusal\u002FLimited Inspection\u003Cbr \u002F>\r\n","","2026-08-18T06:42:29.262718+00:00","2026-08-20T02:24:56.48659+00:00",{"510k":31,"classification":32,"enforcement":33,"event":34,"pma":35,"warning_letter":36},"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"]