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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
506-0824072-2/1/1 01-Dec-2011 64TAR99 2210396 Novartis Pharmaceuticals Corp.
 
506-0824072-2/2/1 01-Dec-2011 64TAR99 2210396 Novartis Pharmaceuticals Corp.
 
231-0041845-2/1/1 01-Dec-2011 63ECS26 3005256773 Albany Molecular Research Inc
 
112-4396138-5/1/1 05-Dec-2011 54FCR12 3006036229 Novel Ingredient Services, LLC
 
BDD-0712296-9/7/1 05-Dec-2011 86MVN 1000222023 Johnson & Johnson Vision Care, Inc.
 
BDD-0712296-9/7/2 05-Dec-2011 86MVN 1000329276 Ciba Vision Corporation
 
BDD-0712296-9/7/3 05-Dec-2011 86MVN 1000329276 Ciba Vision Corporation
 
112-4555549-0/1/1 05-Dec-2011 79GBN 3009184555 Micall Technologies
 
112-3872609-0/1/1 05-Dec-2011 53HD05 3008063607 Young Nails Inc
 
112-3872609-0/1/2 05-Dec-2011 53HD05 3008063607 Young Nails Inc
 
112-3872609-0/1/3 05-Dec-2011 53HD05 3008063607 Young Nails Inc
 
112-3872609-0/1/4 05-Dec-2011 53HD05 3008063607 Young Nails Inc
 
112-3872609-0/1/5 05-Dec-2011 53HD05 3008063607 Young Nails Inc
 
112-3872609-0/1/6 05-Dec-2011 53HD99 3008063607 Young Nails Inc
 
112-3872609-0/1/7 05-Dec-2011 53HD99 3008063607 Young Nails Inc
 
112-3872609-0/1/8 05-Dec-2011 53J99 3008063607 Young Nails Inc
 
112-3872609-0/1/9 05-Dec-2011 53HD05 3008063607 Young Nails Inc
 
112-3872609-0/1/10 05-Dec-2011 53HD05 3008063607 Young Nails Inc
 
112-3872609-0/1/11 05-Dec-2011 53HD06 3008063607 Young Nails Inc
 
112-3872609-0/1/12 05-Dec-2011 53HD05 3008063607 Young Nails Inc
 
112-4225543-3/1/1 06-Dec-2011 65QOP22 1000429220 Baxter Healthcare Corp
 
112-4225543-3/1/2 06-Dec-2011 68XCA10 1000429220 Baxter Healthcare Corp
 
112-2967990-2/1/1 07-Dec-2011 87LXH 1000517406 Paragon Medical
 
112-2967990-2/1/2 07-Dec-2011 79GEF 1000517406 Paragon Medical
 
112-2967990-2/1/14 07-Dec-2011 87HXX 1000517406 Paragon Medical
 
112-2967990-2/1/16 07-Dec-2011 79GEF 1000517406 Paragon Medical
 
112-2967990-2/1/18 07-Dec-2011 87LXH 1000517406 Paragon Medical
 
112-2967990-2/1/3 07-Dec-2011 87LXH 1000517406 Paragon Medical
 
112-2967990-2/1/4 07-Dec-2011 87NBH 1000517406 Paragon Medical
 
112-2967990-2/1/5 07-Dec-2011 87HXX 1000517406 Paragon Medical
 
112-2967990-2/1/6 07-Dec-2011 87LXH 1000517406 Paragon Medical
 
112-2967990-2/1/7 07-Dec-2011 79GEF 1221934 DePuy Mitek, Inc., a Johnson & Johnson Co.
 
112-2967990-2/1/8 07-Dec-2011 87LXH 1000517406 Paragon Medical
 
112-2967990-2/1/9 07-Dec-2011 87NBH 1221934 DePuy Mitek, Inc., a Johnson & Johnson Co.
 
112-2967990-2/1/12 07-Dec-2011 87LXH 1000517406 Paragon Medical
 
112-2967990-2/1/15 07-Dec-2011 87LXH 1000517406 Paragon Medical
 
112-2967990-2/1/17 07-Dec-2011 87HXX 1000517406 Paragon Medical
 
112-2967990-2/1/19 07-Dec-2011 87LXH 3000717687 Advantis Medical
 
112-2967990-2/1/10 07-Dec-2011 87LXH 1221934 DePuy Mitek, Inc., a Johnson & Johnson Co.
 
112-2967990-2/1/11 07-Dec-2011 87NBH 1221934 DePuy Mitek, Inc., a Johnson & Johnson Co.
 
112-2967990-2/1/13 07-Dec-2011 87LXH 1000517406 Paragon Medical
 
112-2409513-8/1/1 07-Dec-2011 85HIS 3002921123 Paradise Marketing Services, Inc.
 
UPS-4294410-4/1/1 09-Dec-2011 76EIS 3003490324 Dent Corp
 
M42-1246644-3/2/1 09-Dec-2011 23AYB11 3004270789 Primex Farms, LLC.
 
112-2404742-8/1/1 12-Dec-2011 65LBJ99 3008935133 Body Ship
 
112-2404742-8/1/2 12-Dec-2011 65LBJ99 3008935133 Body Ship
 
112-2404742-8/1/3 12-Dec-2011 53LD06 3008935133 Body Ship
 
112-2404742-8/1/4 12-Dec-2011 53LD06 3008935133 Body Ship
 
112-2404742-8/1/5 12-Dec-2011 65LBJ99 3008935133 Body Ship
 
112-2377916-1/1/1 12-Dec-2011 66FCA05 2523348 Mutual Pharmaceutical Company, Inc.
 
112-2241351-5/4/4 12-Dec-2011 76EJF 2016150 Ormco/Sybronendo
 
112-2241351-5/4/2 12-Dec-2011 76EJF 2016150 Ormco/Sybronendo
 
112-2241351-5/4/3 12-Dec-2011 76EJF 2016150 Ormco/Sybronendo
 
112-2241351-5/4/1 12-Dec-2011 76EJF 2016150 Ormco/Sybronendo
 
112-0454624-1/1/1 12-Dec-2011 79MFJ 3003766209 Tyco Healthcare
 
551-8839019-4/7/1 13-Dec-2011 41YYH99 3000194002 Datrex Inc
 
112-9841929-5/1/1 13-Dec-2011 95L22 3004752382 Jds Uniphase Corporation
 
112-5570502-6/1/1 13-Dec-2011 62IIK99 3004034219 Bristol Meyers Squibb
 
112-5570502-6/2/1 13-Dec-2011 62IBK99 3004034219 Bristol Meyers Squibb
 
112-5570502-6/2/2 13-Dec-2011 62IIK99 3004034219 Bristol Meyers Squibb
 
112-2158820-0/2/1 13-Dec-2011 61JCA15 2650155 MSD International GmbH (Puerto Rico Branch) LLC
 
112-8428927-2/1/3 13-Dec-2011 62UBK11 2416101 Pfizer Inc.
 
112-8428927-2/1/1 13-Dec-2011 62UBK11 1000145558 Mcneil Consumer Prods Co
 
112-8428927-2/1/2 13-Dec-2011 56FAO13 1317759 Ultra-Seal Corporation
 
112-0645670-4/1/1 13-Dec-2011 61ECB99 1510690 Boehringer Ingelheim Roxane Inc
 
BDD-0712296-9/3/2 15-Dec-2011 86HQG 3009192939 Essilor Of America Inc
 
BDD-0712296-9/3/1 15-Dec-2011 86HQG 3009192939 Essilor Of America Inc
 
112-4690780-5/1/1 16-Dec-2011 64MCK14 3007148938 Serono Laboratories Inc
 
112-4762517-4/1/1 16-Dec-2011 87LXI 1045834 The Anspach Effort, Inc.
 
112-4853861-6/1/1 16-Dec-2011 74NIQ 3005516812 Spectraytics
 
112-4899995-0/1/1 16-Dec-2011 66VIY99 1000198729 Medimmune LLC
 
112-4899995-0/2/1 16-Dec-2011 66VIY99 1000198729 Medimmune LLC
 
112-1650672-0/1/1 16-Dec-2011 61LCL40 1610287 Alcon Research, Ltd.
 
112-5234770-8/2/1 19-Dec-2011 86HQY 3000131631 Burton Corporation
 
112-4809258-2/1/1 19-Dec-2011 79GEI 1000132435 Stryker Sustainability Solutions, Inc.
 
AEK-8961199-6/2/1 19-Dec-2011 53LC06 3003253414 Urban Decay Cosmetics Llc
 
AEK-8963895-7/1/1/C 19-Dec-2011 78NHU 2246912 Vita Pure Inc
 
109-0844139-6/1/1 20-Dec-2011 64ACR99 2219682 DSHealthcare Inc.
 
109-0844139-6/12/2 20-Dec-2011 63RCJ04 3002088145 DENTSPLY Professional
 
AEK-8617590-4/1/1 20-Dec-2011 73CAW 1319044 AirSep Corporation
 
BBH-3014346-1/1/1 20-Dec-2011 53LG09 3009203990 Zo Skin Health
 
112-6149483-8/4/1 27-Dec-2011 33YEY99 3007321039 Chocolate, Arte Y
 
112-0138668-2/1/1 27-Dec-2011 86HJF 3006048844 Innovative Optics, Inc
 
620-2006433-3/1/1 28-Dec-2011 74LOZ 3003761017 SynCardia Systems Inc.
 
112-2388558-8/1/1 28-Dec-2011 95RDW 3002875134 Juki Automation Systems, Inc.
 
112-4050395-8/1/1 28-Dec-2011 61ECQ04 2518137 AstraZeneca Pharmaceuticals LP
 
112-4375475-6/1/1 28-Dec-2011 87JDG 3008035425 Maxx Orthopedics Inc
 
112-3215343-2/1/1 28-Dec-2011 65PDA02 2416101 Pfizer Inc.
 
112-8112597-3/1/1/A 28-Dec-2011 80FMF 2243072 Becton Dickinson & Company
 
112-9775674-8/1/1 28-Dec-2011 60LIA83 2245314 Catalent Pharma Solutions
 
112-9839425-9/1/1 28-Dec-2011 56ECA20 3006218434 Tolmar, Inc.
 
112-9839425-9/1/2 28-Dec-2011 56ECA20 3006218434 Tolmar, Inc.
 
UPS-4759516-6/1/1 29-Dec-2011 53LC10 3009283394 Flawless Effect
 
112-0260793-8/1/1 30-Dec-2011 61LCP29 3008695133 Aventis
 
112-3418383-3/1/1 30-Dec-2011 66VCE99 2511504 Glenwood, LLC
 
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