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U.S. Department of Health and Human Services

Import Refusal Report

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Refusal Actions by FDA as Recorded in OASIS

for United States


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
UPS-2954767-2/2/1 03-Aug-2011 54YCY99 1000518758 Naturalife Eco Vite Laboratories, Inc
 
UPS-3223955-6/1/2 03-Aug-2011 54FBZ99 3007581867 Healthforce Nutrition
 
UPS-3223955-6/1/1 03-Aug-2011 54FBZ99 3007581867 Healthforce Nutrition
 
112-2639966-0/1/1 04-Aug-2011 80FPA 3004193065 Braun Medical
 
315-8159826-0/197/1 04-Aug-2011 89ISA 2131125 Sybaritic, Inc
 
AV3-0023559-3/1/4 05-Aug-2011 66VBL99 1000526880 Reckitt Benckiser Inc
 
112-7303993-7/1/1 05-Aug-2011 86HQY 3003981121 Tifosi Optics Inc
 
112-8031821-7/1/1 05-Aug-2011 61LCK29 3005167197 Sanofi-Aventis
 
112-5880721-7/1/1 05-Aug-2011 74DTL 1033554 DeRoyal Industries, Inc.
 
112-5864338-0/1/1 05-Aug-2011 95L22 3006317583 Fedex Repair Center
 
112-5383646-8/1/1 05-Aug-2011 62VIS99 3006031727 Alexion Pharmaceuticals, Inc.
 
112-7240622-8/7/1 05-Aug-2011 54YIY99 1037555 Capsugel Manufacturing
 
112-8247534-6/1/1 08-Aug-2011 64XCB11 1110315 Mylan Pharmaceuticals Inc.
 
231-2844798-8/1/1 09-Aug-2011 20AYH10 2912719 Mariani Packing Co., Inc.
 
BGK-0380123-1/1/1 09-Aug-2011 05BFT01 3003801944 ITN Food Corporation USA, Inc.
 
BGK-0380123-1/2/1 09-Aug-2011 05BFT01 3003801944 ITN Food Corporation USA, Inc.
 
BGK-0380123-1/28/1 09-Aug-2011 05BFT01 3003801944 ITN Food Corporation USA, Inc.
 
EG6-2143258-2/1/1/A 09-Aug-2011 53CD06 3007997612 Maybelline Llc
 
112-2472193-1/1/1 10-Aug-2011 61MCB30 3008363465 Abbott Biotechnology Ltd
 
BJV-0241774-0/7/3 10-Aug-2011 62HBL99 3004932373 CareFusion 213, LLC
 
BJV-0241774-0/7/5 10-Aug-2011 62HBL99 3004932373 CareFusion 213, LLC
 
BJV-0241774-0/7/7 10-Aug-2011 62HBL99 3004932373 CareFusion 213, LLC
 
BJV-0241774-0/7/8 10-Aug-2011 62HBL99 3004932373 CareFusion 213, LLC
 
BJV-0241774-0/39/1 10-Aug-2011 62FAL34 1120159 Aplicare Incorporated
 
BJV-0241774-0/40/2 10-Aug-2011 62FAL34 1120159 Aplicare Incorporated
 
BJV-0241774-0/65/3 10-Aug-2011 62FAL34 2411192 Professional Disposables International, Inc.
 
BJV-0241818-5/12/1 10-Aug-2011 62HBL99 3004932373 CareFusion 213, LLC
 
BJV-0241818-5/13/3 10-Aug-2011 62HBL99 3004932373 CareFusion 213, LLC
 
BJV-0241818-5/15/1 10-Aug-2011 62FAL23 1220701 Aplicare, Inc.
 
BJV-0241818-5/19/1 10-Aug-2011 62FBK20 1484185 3M Company
 
BJV-0241818-5/19/2 10-Aug-2011 62FBK20 1484185 3M Company
 
BJV-0241818-5/31/1 10-Aug-2011 62HBL99 3004932373 CareFusion 213, LLC
 
BJV-0242016-5/4/5 10-Aug-2011 62HBL99 3004932373 CareFusion 213, LLC
 
BJV-0242016-5/4/6 10-Aug-2011 62HBL99 3004932373 CareFusion 213, LLC
 
BJV-0242016-5/4/7 10-Aug-2011 62HBL99 3004932373 CareFusion 213, LLC
 
BJV-0242016-5/11/11 10-Aug-2011 62FAK34 1220701 Aplicare, Inc.
 
BJV-0242016-5/13/1 10-Aug-2011 62FAK34 1220701 Aplicare, Inc.
 
BJV-0242016-5/13/2 10-Aug-2011 62HBL99 3004932373 CareFusion 213, LLC
 
BJV-0242016-5/13/3 10-Aug-2011 62HBL99 3004932373 CareFusion 213, LLC
 
BJV-0242016-5/30/1 10-Aug-2011 62FAL34 1120159 Aplicare Incorporated
 
BJV-0242016-5/34/1 10-Aug-2011 62FBK20 1484185 3M Company
 
004-5998192-4/2/1 10-Aug-2011 78FGE 1000220862 Micro Therapeutics Inc, Dba Ev3 Neurovascular
 
004-5998192-4/3/1 10-Aug-2011 74LIT 2183870 Ev3, Inc.
 
004-5998192-4/5/1 10-Aug-2011 74MCW 2183870 Ev3, Inc.
 
004-5998192-4/6/1/A 10-Aug-2011 78FGE 2183870 Ev3, Inc.
 
004-5998192-4/6/1/B 10-Aug-2011 84NJE 2183870 Ev3, Inc.
 
004-5998192-4/6/1/C 10-Aug-2011 78FGE 2183870 Ev3, Inc.
 
004-5998192-4/6/1/D 10-Aug-2011 74LIT 2183870 Ev3, Inc.
 
004-5998192-4/7/1 10-Aug-2011 78FGE 2183870 Ev3, Inc.
 
004-5998192-4/8/1 10-Aug-2011 74NIM 2183870 Ev3, Inc.
 
004-5998192-4/9/1 10-Aug-2011 78FGE 2183870 Ev3, Inc.
 
004-5998192-4/10/1 10-Aug-2011 84HCG 2183870 Ev3, Inc.
 
004-5998192-4/12/1 10-Aug-2011 74NFA 2183870 Ev3, Inc.
 
004-5998192-4/13/1 10-Aug-2011 78FGE 2183870 Ev3, Inc.
 
BJV-0242156-9/3/1 10-Aug-2011 62FBK20 1484185 3M Company
 
BJV-0242156-9/10/1 10-Aug-2011 62HBL99 3004932373 CareFusion 213, LLC
 
BJV-0242255-9/4/2 10-Aug-2011 62HBL99 3004932373 CareFusion 213, LLC
 
BJV-0242255-9/6/3 10-Aug-2011 62HBL99 3004932373 CareFusion 213, LLC
 
BJV-0242255-9/13/1 10-Aug-2011 62FBL08 2411192 Professional Disposables International, Inc.
 
BJV-0242577-6/7/1 10-Aug-2011 62FBK20 1484185 3M Company
 
BJV-0242577-6/7/2 10-Aug-2011 62FBK20 1484185 3M Company
 
BJV-0242577-6/7/3 10-Aug-2011 62FBK20 1484185 3M Company
 
BJV-0242577-6/11/1 10-Aug-2011 62HBL99 3004932373 CareFusion 213, LLC
 
112-2695950-5/1/1 16-Aug-2011 86HQY 3006068575 Tuscany Eyewear
 
UPS-3112188-8/1/1 19-Aug-2011 56BJY03 2416101 Pfizer Inc.
 
112-5751635-5/1/1 19-Aug-2011 66VQY99 1000125593 Constant Irwindale, Inc.
 
112-2864832-0/1/1 19-Aug-2011 60QAO67 1811212 Ferndale Laboratories, Inc.
 
112-2864832-0/1/2 19-Aug-2011 60QAO67 1811212 Ferndale Laboratories, Inc.
 
112-1514137-0/1/1 23-Aug-2011 77NAS 2113281 Diagnostic Group LLC
 
112-2574790-1/1/3 23-Aug-2011 54FIZ95 3008954112 Swami And Company
 
112-2574790-1/1/7 23-Aug-2011 54FIZ95 3008954112 Swami And Company
 
112-2574790-1/1/4 23-Aug-2011 54FIZ95 3008954112 Swami And Company
 
112-2574790-1/1/2 23-Aug-2011 54FIZ95 3008954112 Swami And Company
 
112-2574790-1/1/1 23-Aug-2011 54FIZ95 3008954112 Swami And Company
 
112-2574790-1/1/8 23-Aug-2011 54FIZ95 3008954112 Swami And Company
 
112-2574790-1/1/5 23-Aug-2011 54FIZ95 3008954112 Swami And Company
 
112-2574790-1/1/6 23-Aug-2011 54FIZ95 3008954112 Swami And Company
 
112-2864911-2/2/1 23-Aug-2011 62VCB15 1000523075 Gilead Sciences, Inc.
 
112-2549559-2/1/1 23-Aug-2011 79HXM 3006142527 Black & Black Surgical Inc
 
112-2549559-2/1/2 23-Aug-2011 79LRW 3006142527 Black & Black Surgical Inc
 
GEO-6402797-8/1/1 23-Aug-2011 66VCY99 1000135041 Bellegrove Medical Supply
 
112-1174606-5/1/1 23-Aug-2011 90ITX 3001701594 Protek Medical Products Inc
 
112-0479586-3/1/1 23-Aug-2011 95RDW 3003947090 Image Map
 
112-0219616-3/1/1 24-Aug-2011 55YP99 2242462 Thermo Fisher Scientific
 
112-0119352-6/1/1 24-Aug-2011 75NBW 3007172347 Sanmina-Sci Corp
 
112-0101786-5/1/1 24-Aug-2011 80FRN 3005750701 Med Assoc Inc
 
112-3463812-5/36/1 24-Aug-2011 79KGO 1000374923 3m Health Care
 
112-3463812-5/46/1 24-Aug-2011 80OIG 1000374923 3m Health Care
 
112-3463812-5/58/1 24-Aug-2011 73NVP 1000429220 Baxter Healthcare Corp
 
112-3463812-5/58/3 24-Aug-2011 73BYG 3004008697 Cardinal Health Inc
 
FY6-2008067-8/5/1 24-Aug-2011 60LBA01 3004135577 Novartis
 
FY6-2008067-8/8/1 24-Aug-2011 61VAA01 3004135577 Novartis
 
FY6-2008067-8/9/1 24-Aug-2011 60SBL04 3004135577 Novartis
 
FY6-2008067-8/10/1 24-Aug-2011 60SBL14 3004135577 Novartis
 
FY6-2008067-8/11/1 24-Aug-2011 60SBL04 3004135577 Novartis
 
FY6-2008067-8/12/1 24-Aug-2011 62MAJ08 3004135577 Novartis
 
FY6-2008067-8/13/1 24-Aug-2011 66BAE05 3004135577 Novartis
 
FY6-2008067-8/14/1 24-Aug-2011 60QAJ34 3004135577 Novartis
 
FY6-2008067-8/16/1 24-Aug-2011 60LBR01 3004135577 Novartis
 
FY6-2008067-8/19/1 24-Aug-2011 60LBZ01 3004135577 Novartis
 
112-3246300-5/1/2 24-Aug-2011 64GCA99 3009035375 Beacons Pharma
 
112-3246300-5/1/1 24-Aug-2011 64GCA99 3009035375 Beacons Pharma
 
112-1737036-5/5/3 24-Aug-2011 76EJB 3001124625 Columbia Dentoform Corp
 
112-1737036-5/5/2 24-Aug-2011 76EMR 3003781806 United Dental Manufacturers
 
112-1737036-5/3/1 24-Aug-2011 76OIV 2024312 Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical
 
112-1737036-5/5/1 24-Aug-2011 76EJL 2245654 S.S. White Burs Inc
 
112-1381865-6/2/1 24-Aug-2011 61PCA31 3008125942 Glaxosmithkline Consumer Healthc
 
112-1381865-6/2/2 24-Aug-2011 61PCA31 3008125942 Glaxosmithkline Consumer Healthc
 
D03-0221863-7/1/1/A 25-Aug-2011 86HME 1041845 Marco Ophthalmic, Inc.
 
D03-0221863-7/1/1/B 25-Aug-2011 86HME 1523545 Reliance Medical Products Inc
 
D03-0221863-7/1/1/C 25-Aug-2011 86HME 1219337 American Optical Lens Company
 
D03-0221863-7/3/1/B 25-Aug-2011 86HME 1041845 Marco Ophthalmic, Inc.
 
D03-0221863-7/3/1/C 25-Aug-2011 86HME 1219337 American Optical Lens Company
 
D03-0221863-7/3/1/D 25-Aug-2011 86HME 1523545 Reliance Medical Products Inc
 
D03-0221863-7/8/1 25-Aug-2011 86HJO 2918630 Carl Zeiss Meditec, Inc.
 
D03-0221863-7/10/1 25-Aug-2011 86HOS 1041845 Marco Ophthalmic, Inc.
 
D03-0221863-7/12/1/A 25-Aug-2011 86HKY 1219337 American Optical Lens Company
 
D03-0221863-7/12/1/B 25-Aug-2011 86HKY 1000159913 Reichert, Inc.
 
D03-0221863-7/12/1/C 25-Aug-2011 86HKY 2519784 Keeler Instruments Inc
 
D03-0221863-7/15/1 25-Aug-2011 86HKN 2918630 Carl Zeiss Meditec, Inc.
 
D03-0221863-7/16/1/A 25-Aug-2011 86HLM 2918630 Carl Zeiss Meditec, Inc.
 
D03-0221863-7/16/1/B 25-Aug-2011 86HLM 1313525 Bausch & Lomb Inc
 
D03-0221863-7/16/1/C 25-Aug-2011 86HLM 1041845 Marco Ophthalmic, Inc.
 
D03-0221863-7/16/1/D 25-Aug-2011 86HLM 1000159913 Reichert, Inc.
 
U35-1990954-3/1/1 25-Aug-2011 90JAK 1000506423 Ge Medical Systems
 
U35-1991274-5/1/1 25-Aug-2011 90JAK 1000506423 Ge Medical Systems
 
112-9710601-9/1/2 26-Aug-2011 62IQA99 3003563645 Catalent Pharma Solutions, LLC
 
112-9710601-9/1/1 26-Aug-2011 62IQA99 3003563645 Catalent Pharma Solutions, LLC
 
UPS-3224181-8/1/1 31-Aug-2011 66VBK99 3007487015 Dynamiclear Inc.
 
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