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OMUFA Facility Arrears List Thursday, August 26, 2021

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OMUFA Facility Arrears List Thursday, August 26, 2021 OMUFA Facility Arrears List Friday, September 10, 2021 The following facilities have not satisfied the annual Over-The-Counter (OTC) Monograph User Fee Program (OMUFA) facility fee(s) as required under section 744M of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as added by the Coronavirus Aid, Relief, and Economic Security Act (or the “CARES Act”), under which FDA will assess and collect fees from submitters of OTC Monograph Order Requests (OMORs) as well as facility fees from qualifying manufacturers of OTC monograph drugs. The facility fee was due no later than May 10, 2021, for fiscal year (FY) 2021. If a facility does not pay the annual facility fee within 20 calendar days of the due date, the Agency will place the facility on a publicly available arrears list, and all OTC monograph drug products produced at that facility (or containing an ingredient manufactured at that facility) shall be deemed misbranded under section 502(ff) of the FD&C Act. Additionally, OMORs and meeting requests related to OMORs will not be accepted from persons, or their affiliate(s) in arrears (see section 744M(e) of the FD&C Act). We encourage you to seek verification from your business partners that all applicable fee(s) have been received in full by the Agency. If your records indicate that an FY 2021 OMUFA facility fee was previously submitted, please contact [email protected] and provide the following information: • Facility Name • Dun & Bradstreet (DUNS) number • FDA Establishment Identifier (FEI) Number • User Fee Payment I.D. Number (PIN) • Payment method, date, and amount Additionally, if you believe that your facility is not subject to OMUFA facility fees, please contact [email protected] and provide a brief explanation for your reasoning. The Agency will review your explanation and respond to it promptly. FACILITY NAME FEI FY 2021 DUNs Number Number 3ACTLAB 3014652040 MDF 687320221 4E GLOBAL SAPI DE CV 3010078513 MDF 812821307 7774672 CANADA INC DBA DERME & CO 3008917133 MDF 203095039 A2Z PRODUCTS LLC 3014832963 MDF 098609708 ACCEL INC 3003042119 MDF 838933430 ACINO PRODUCTS LIMITED LIABILITY COMPANY 3004723334 CMO 019385518 ACTIV OZONE (PTY) LTD 3013846005 MDF 539181712 ACTIVE INTELLIGENCE LLC 3014556381 MDF 080416593 * These facilities were assessed a Monograph Drug Facility fee; however, the Contract Manufacturing Organization fee was submitted resulting in an underpayment of FY 2021 OMUFA user fee obligations. Page 1 of 32 FACILITY NAME FEI FY 2021 DUNs Number Number AD BIOTECH COLTD 3010239672 MDF 688713049 ADNOVA HEALTHCARE PRIVATE LIMITED 3015593855 MDF 876818471 AEROSOLES FRANCOMEXICANOS SA DE CV 3017570662 MDF 951582146 AESTHETIC PLUS COMPANY LIMITED 3005753252 MDF 660736328 AFASSCO INC 1000122702 MDF 956159800 AG INTERNATIONAL 3015667121 MDF 675480459 AGRICULTURAL CORPORATION SKY&LAKE 688995097 MDF 688995097 AIPC GLOBAL INC 3017136033 MDF 109839111 AJOU MEDICS CO LTD 3010165608 MDF 688796473 AJU COSMETIC CO LTD 3013427100 MDF 689847363 ALBEK DE MEXICO SA DE CV 3009115034 MDF 812321107 * ALCON - COUVREUR 3002037047 MDF 370205429 ALIVE 2 DIVE COMPANY LIMITED 3016453477 MDF 662332223 ALL PHARMA LLC 3017181385 CMO 117605075 ALL PHARMA LLC 3010047167 CMO 078572520 ALMIL NUTRITIONAL PRODUCTS INC 1000125228 MDF 153736301 * These facilities were assessed a Monograph Drug Facility fee; however, the Contract Manufacturing Organization fee was submitted resulting in an underpayment of FY 2021 OMUFA user fee obligations. Page 2 of 32 FACILITY NAME FEI FY 2021 DUNs Number Number ALOE VERA KOREA COLTD 3014810945 MDF 687773350 ALTONA COSMETICS TECHNOLOGY SANAYI VE TICARET 3012382398 MDF 502657469 ANONIM SIRKETI AMAROS CO LTD 3010518986 MDF 690338801 AMERICAN CHEMICAL SYSTEMS II LLC 3016795059 MDF 016631058 AMO (HANGZHOU) CO LTD 3004178847 MDF 420130676 AN CO LTD 3003092574 MDF 688448454 ANC 3018319069 MDF 557791697 ANHUI DONGSHENGYOUBANG PHARMACEUTICAL CO LTD 3012965155 MDF 527929527 ANNE COSMETICS 3010811600 MDF 690377762 APHARM CO LTD 689054266 MDF 689054266 ARG LABORATORIES INC 1000306124 CMO 117433599 ART NOUVEAU 3010165614 MDF 557796198 ASAN C&S 3009453181 MDF 631139649 ASANUMA CORPORATION 3007012465 CMO 715464975 ASANUMA CORPORATION 3010960168 CMO 715464942 ASHAHI CHEMICALS USA LLC 3017483558 MDF 111671300 * These facilities were assessed a Monograph Drug Facility fee; however, the Contract Manufacturing Organization fee was submitted resulting in an underpayment of FY 2021 OMUFA user fee obligations. Page 3 of 32 FACILITY NAME FEI FY 2021 DUNs Number Number ASISTBOYA KIMYA VE MAKINA SANAYI TICARET 595972538 MDF 595972538 LIMITED SIRKETI ASTRAL DEL NOROESTE SA DE CV 3002794020 MDF 814334751 ATEC CO LTD 3012259450 MDF 689276681 ATLAS R&D INC 3010515816 MDF 257836242 AURA COSMETICS INC 3017124329 MDF 696073832 AURELIO MUNOZ SAGAON 3017555570 MDF 951578972 AVADIM HEALTH INC 3006274377 MDF 041443877 AVAJAR CO LTD 3013411273 MDF 689851644 AVASOL LLC 3014630458 MDF 078822898 AVLON INDUSTRIES INC 3007090726 MDF 121278626 AVP LABS AND INVESTMENT GROUP LLC 3016822800 MDF 117579838 BAPS SWAMINARAYAN HERBAL CARE A UNIT OF DIVINE 3004290879 MDF 921183294 ENERGY BASTON INDUSTRIA DE AEROSSOLS LTDA 3012362424 MDF 897727605 BAYSCIENCE FORMULATORS LLC 3006210508 MDF 162930544 BBC INC 3017706037 MDF 694608131 BEAUTY-FACTOR BIOCHEMICAL TECHNOLOGY CO LTD 656368622 MDF 656368622 * These facilities were assessed a Monograph Drug Facility fee; however, the Contract Manufacturing Organization fee was submitted resulting in an underpayment of FY 2021 OMUFA user fee obligations. Page 4 of 32 FACILITY NAME FEI FY 2021 DUNs Number Number BEIJING RIMENG BIOBOGIC TECHNOLOGY CO LTD 3005660579 MDF 527007423 BEIJING TAIJI JIN KANG MEDICAL TECHNOLOGY CO LTD 3016755317 MDF 554530728 BENXI BAICHUAN PHARMACEUTICAL CO LTD 3015234520 MDF 554466418 BERKO ILAC VE KIMYA SANAYI ANONIM SIRKETI 3012452871 CMO 533135007 BERLIN PHARMACEUTICAL INDUSTRY COMPANY 3011953233 MDF 661748158 LIMITED - BRANCH BINOTEC CO LTD 689840563 MDF 689840563 BIO EARTH MANUFACTURING (PTY) LTD 3014120086 MDF 639768436 BIOGENESIS INC 3004933570 MDF 069117328 BIOMYLZ PVT LTD 3013697420 CMO 675466955 BIOSTECH CO LTD 3012845783 MDF 687294330 BIOTEK INDIA 3015394334 MDF 675484458 BLUE POWER GROUP LTD 3005301726 MDF 873273767 BLUE SEA AEROSOL & DAILY CARE CO LTD 3014499397 MDF 544373091 BMC 1092INC DBA SOLO LABORATORIES INC 3003087073 CMO 078831987 BMONUMENT CO LTD 3014357926 MDF 694624625 BOCCHI LABORATORIES 3008006558 MDF 013579387 * These facilities were assessed a Monograph Drug Facility fee; however, the Contract Manufacturing Organization fee was submitted resulting in an underpayment of FY 2021 OMUFA user fee obligations. Page 5 of 32 FACILITY NAME FEI FY 2021 DUNs Number Number BOSTON NUTRACEUTICAL PRODUCTION SL 3014417356 MDF 468121064 BOYA BIOTECHNOLOGY COMPANY LIMITED 3015538858 MDF 403701144 BPS 60 3008238035 MDF 272259304 BR 3013716261 MDF 689605100 BRCOSMETIC 3018544870 MDF 695596476 BRILLIANT 690381938 MDF 690381938 BSK GRUP KIMYA SANAYI VE TICARET LIMITED SIRKETI 3017679590 MDF 595676471 BSOLVE LIMITED 3008847596 MDF 734555951 BTC TOP INC 3017224474 CMO 113123620 BUENO MEDITECH 695687664 MDF 695687664 C&T DREAM CO LTD 3013632824 MDF 694699750 C&TECH CORPORATION 3007420167 MDF 688204698 C3 CO LTD 3011316036 MDF 689846633 CALFARME SINGAPORE PTE LTD 3014275859 MDF 595222746 CAMPUSORG TURIZM ORGANIZASYON REKLAMCILIK 3016783508 MDF 519903395 PAZARLAMA SANAYI VE TICARET LIMITED SIRKETI CARING JAPAN INC 3007876103 MDF 702171786 * These facilities were assessed a Monograph Drug Facility fee; however, the Contract Manufacturing Organization fee was submitted resulting in an underpayment of FY 2021 OMUFA user fee obligations. Page 6 of 32 FACILITY NAME FEI FY 2021 DUNs Number Number CARROLLCLEAN LLC 1611690 MDF 081222623 CELBLOS DERMAL RESEARCH CENTRE PRIVATE LIMITED 3010024807 MDF 659110811 C'ELLA CO LTD 3010858038 MDF 692745698 CELLAB CO LTD 3009426136 MDF 688195494 CENTRO INTERNACIONAL DE COSMIATRIA SAPI DE CV 3012568137 MDF 814124954 CHARMING COSMETICS CO LTD 3013068404 MDF 689935740 CHINA RESOURCES SANJIU MEDICAL & 3010533926 MDF 544695711 PHARMACEUTICAL CO LTD CHOICE ALL NATURAL INC D 103340792 MDF 103340792 CJ LABS INC 3005656496 MDF 602459476 CLEOSLAB COLTD 3017306575 MDF 695903219 CLIENTELE INC 3012481086 MDF 085021806 COASTAL CONTRACT PACKAGING INC 3004713804 CMO 137341611 CODENATURE INC 690242086 MDF 690242086 COFRAN INTERNATIONAL CORP 1000163040 MDF 122716855 COIZ CO LTD 3014442295 MDF 688382956 COLOR DESIGN LABORATORY INC 3010779331 CMO 837941108 * These facilities were assessed a Monograph Drug Facility fee; however, the Contract Manufacturing Organization fee was submitted resulting in an underpayment of FY 2021 OMUFA user fee obligations. Page 7 of 32 FACILITY NAME FEI FY 2021 DUNs Number Number COLORFUL PRODUCTS CORP 2083633 CMO 082696105 COMPANIA FARMACEUTICA SA DE CV 3004477088 MDF 816053340 CONSOLIDATED CHEMICAL INC DBA CARE-TECH 1940465 MDF 006306674 LABORATORIES INC CONSUMER PACKAGING GROUP INC 3006114458 MDF 612465950 COSMAX CHINA INC 3009347981 MDF 545368016 COSMESIT SRL 3015458705 MDF 339071951 COSMOCOS CO LTD 3012834651 MDF 689387376 COSMOLIVE KOZMETIK SANAYI VE TICARET ANONIM 3016777559 MDF 595671824 SIRKETI COSNINE INC 3014350719 MDF 694607163 COSON CO LTD_OSAN PLANT 3010164718 MDF 689847210 COSPRO DEVELOPMENT CORP 3005123499 MDF 785638821 CREATIVE SUPPLY SOLUTION LTD 3017984767 MDF 671473247 CU LIFESTYLE LLC 3015192460 MDF 010080461 CUSTOM RESEARCH LABS INC 3008268262 MDF 028611598 DAFFY HEALTHCARE PRIVATE LIMITED 3015464211 CMO 862586251
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