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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 66-Human and Animal Drugs


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
AQ1-3011362-6/1/1/B 19-May-2005 66BDY99 3005063986 Duo Collection Inc United States
 
112-6970301-3/1/1 19-May-2005 66BIY99 3005121893 Pfizer Inc United States
 
H67-1248253-7/13/1 06-May-2005 66FAY99 3004666971 RAMON SERRANO El Salvador
 
112-6320567-6/1/1 04-May-2005 66JCA01 3005027523 Cariboo Monashee H Canada
 
112-6556892-3/1/1 31-May-2005 66JCP05 3005061867 Sharma Tvl Canada
 
112-6432939-2/6/1 23-May-2005 66JCY01 3003615524 Glaxo Smith Kline India
 
AEK-6662487-1/2/1 04-May-2005 66MCA61 3005051913 Fr De Luzuriaga Philippines
 
310-9573705-7/3/1 26-May-2005 66MCA86 3004955355 Zrihen Jacques Canada
 
310-9578059-4/1/1 26-May-2005 66MCB86 3004633995 Lovell Drugs Canada
 
310-9579193-0/6/1 26-May-2005 66MCF95 3005047636 Debbie Wood Canada
 
310-9577109-8/4/1 26-May-2005 66MCF95 3005013010 Barkman Concrete Canada
 
G32-0126637-3/1/1 19-May-2005 66MCS86 3002913672 Assia Chemical Industries - Teva Tech Site Israel
 
K48-0568942-9/1/1 18-May-2005 66PAS99 3003468419 Kuo Ching Chemical Co. Taiwan
 
P09-3039689-3/10/12 14-May-2005 66PBJ07 8012 Clarins France
 
WO1-1069181-4/2/7 03-May-2005 66PBJ99 3002968450 Sogeci France
 
AWL-0707545-3/46/2 12-May-2005 66PBJ99 3004662723 Star Exports Philippines
 
AWL-0707545-3/46/3 12-May-2005 66PBJ99 3004662723 Star Exports Philippines
 
P09-3039692-7/1/2 14-May-2005 66PBJ99 8012 Clarins France
 
P09-3039692-7/1/5 14-May-2005 66PBJ99 8012 Clarins France
 
P09-3038825-4/2/9 14-May-2005 66PBJ99 3004016665 Biotherm Sofamo Monaco
 
P09-3038825-4/2/3 14-May-2005 66PBJ99 3004016665 Biotherm Sofamo Monaco
 
U29-0169740-1/37/1 27-May-2005 66PBJ99 3002717900 Lee Hoong Kee China Packing Co China
 
U29-0169740-1/38/1 27-May-2005 66PBJ99 3002717900 Lee Hoong Kee China Packing Co China
 
AEK-6661420-3/2/2 03-May-2005 66SCA48 3005036416 Joe Familar Philippines
 
AEK-7039681-3/1/1 25-May-2005 66SCA48 3005101572 Mr Roy Harb Lebanon
 
AEK-6663744-4/2/1 03-May-2005 66SCE27 3004753603 Billy Reseno Philippines
 
XXX-0113915-4/1/1/B 10-May-2005 66SCF27 3001015165 Gelcaps Exportadora De Mexico, S.A. De C.V. Mexico
 
AEK-6528536-9/1/1 12-May-2005 66V99 3005039323 Vinka Vukicevic Canada
 
AEK-6528536-9/1/2 12-May-2005 66V99 3005039323 Vinka Vukicevic Canada
 
HK1-0150317-3/4/1 19-May-2005 66V99 3004336201 VSF SDN BHD Malaysia
 
AEK-6554444-3/1/1 23-May-2005 66V99 3005117249 Kantzos Greece
 
AEK-6554444-3/1/2 23-May-2005 66V99 3005117249 Kantzos Greece
 
575-0249992-4/1/2 03-May-2005 66VAE99 3003787333 Enerex Botanicals Ltd Canada
 
AEK-7444634-1/1/1 13-May-2005 66VAH99 2000031517 Nanjing Zhongke Group Corp., Ltd. China
 
AEK-7040364-3/1/1 25-May-2005 66VAK99 3004954696 Centurion South Africa
 
K80-0904295-4/20/1 04-May-2005 66VAL99 3004348364 P. J. Exports India
 
AEK-7038417-3/1/1 05-May-2005 66VAL99 3004646078 Postnet Westgate South Africa
 
DO7-0093696-9/1/1 26-May-2005 66VAL99 3003671617 Sawhney Brothers India
 
AEK-7040279-3/1/1 25-May-2005 66VAR99 3005105823 Charles Amedu Nigeria
 
AEK-7039948-6/1/1 25-May-2005 66VAR99 3005103076 Andrew Odionose Onoabhagbe Nigeria
 
575-0249992-4/1/1 03-May-2005 66VAS99 3003787333 Enerex Botanicals Ltd Canada
 
ES2-0042468-8/1/1 13-May-2005 66VAY99 3005012427 Tese Natural Health Group Inc. United States
 
GL5-0738971-3/1/1 19-May-2005 66VBA99 3004249848 Xing Da Herbal Processing Factory China
 
112-6418321-1/1/1 10-May-2005 66VBF99 3003645093 Shree Baidyanath Ayurved Bhawan India
 
112-6571494-9/1/2 11-May-2005 66VBJ99 1000156146 Cheminova International Sa Spain
 
277-0107166-7/13/1 14-May-2005 66VBJ99 3004116897 Mondey Holding Peach Brand Co Ltd Thailand
 
AYG-1000515-0/16/1 25-May-2005 66VBJ99 3003726991 M/S Vicco Laboratories India
 
K80-0902342-6/10/7 04-May-2005 66VBL99 3004348364 P. J. Exports India
 
112-6571494-9/1/1 11-May-2005 66VBL99 1000156146 Cheminova International Sa Spain
 
AEK-7024018-5/1/1 23-May-2005 66VBL99 3003304350 First Flight Courier United Arab Emirates
 
WUG-0127282-1/20/1 27-May-2005 66VBL99 3004974700 Wilson Medicine Co India
 
WUG-0127282-1/22/2 27-May-2005 66VBL99 3004659877 Hamdard (Wakf) Laboratories India
 
WUG-0127678-0/21/3 13-May-2005 66VBR99 3001690094 Sudip And Company India
 
WUG-0127966-9/19/2 19-May-2005 66VBR99 3004326849 Dabur India Limited India
 
002-6121964-6/7/1 13-May-2005 66VBS99 3004518571 Ashraf Abd El Maksoud Ahmed Egypt
 
880-0049516-3/9/1 04-May-2005 66VBY99 3004270719 Osotspa Co., Ltd. Thailand
 
WUG-0127966-9/6/1 19-May-2005 66VBY99 3007918666 Vicco Laboratories India
 
AYB-2151832-9/1/1/A 23-May-2005 66VBY99 3004096041 Splash Corporation Philippines
 
AYB-2151832-9/1/1/B 23-May-2005 66VBY99 3004096041 Splash Corporation Philippines
 
AYB-2151832-9/1/1/D 23-May-2005 66VBY99 3004096041 Splash Corporation Philippines
 
AYG-1000515-0/64/1 25-May-2005 66VBY99 3005081951 Procter & Gamble Hygiene and Health Care Limited India
 
AYG-1000515-0/65/1 25-May-2005 66VBY99 3006686155 Proctor & Gamble Hygiene And Health Care India
 
ES2-0042468-8/1/2 13-May-2005 66VBZ99 3005012427 Tese Natural Health Group Inc. United States
 
DO7-0092027-8/1/1 24-May-2005 66VCA99 3004082347 Cipla Ltd. India
 
AEK-6664837-5/2/1 12-May-2005 66VCB99 3005085851 Nancy Manoloto Philippines
 
AEK-6664837-5/4/1 12-May-2005 66VCE99 3005085851 Nancy Manoloto Philippines
 
DO7-0092029-4/1/1 24-May-2005 66VCE99 3004970240 Djokwe Lee Cameroon
 
110-0991948-5/1/1/C 27-May-2005 66VCK99 1000460924 Ups/Kaf Korea, Republic Of (South)
 
110-0991948-5/1/1/D 27-May-2005 66VCK99 1000460924 Ups/Kaf Korea, Republic Of (South)
 
110-0991948-5/1/1/E 27-May-2005 66VCK99 1000460924 Ups/Kaf Korea, Republic Of (South)
 
110-0991948-5/1/1/G 27-May-2005 66VCK99 1000460924 Ups/Kaf Korea, Republic Of (South)
 
110-0991948-5/1/1/H 27-May-2005 66VCK99 1000460924 Ups/Kaf Korea, Republic Of (South)
 
110-0991948-5/1/1/I 27-May-2005 66VCK99 1000460924 Ups/Kaf Korea, Republic Of (South)
 
411-8151583-8/11/1 27-May-2005 66VCL99 3003244915 TTK Healthcare Limited India
 
XXX-0115110-0/1/1 03-May-2005 66VCP99 1000646030 Rotta Research Laboratorium Italy
 
112-6277133-0/1/1 04-May-2005 66VCP99 3005021004 Mrs Alita Indonesia
 
112-6270888-6/1/2 05-May-2005 66VCP99 3005019872 Icn Farnacetica Mexico
 
112-6148685-6/1/1 11-May-2005 66VCP99 3005002056 Liberty Healthcare Netherlands
 
112-6272331-5/1/1 11-May-2005 66VCP99 3005020117 Roche Products P/L Australia
 
112-6272331-5/1/2 11-May-2005 66VCP99 3001672015 Eli Lilly Pty Ltd Australia
 
112-6543516-4/1/1 31-May-2005 66VCP99 3005059582 Merck Sharp & Dohme Scientific Office Egypt
 
112-6543516-4/1/2 31-May-2005 66VCP99 3005059581 Aventis Pharma Egypt
 
112-6543516-4/1/3 31-May-2005 66VCP99 3004582708 Alkan Pharma Egypt
 
H79-1581471-6/1/1 18-May-2005 66VCR99 3004060322 Sinochem Jiangsu China
 
T94-0038893-8/9/1 27-May-2005 66VCS99 3002878716 Super Exports India
 
112-6527081-9/1/1 03-May-2005 66VCY99 3005057060 Danlex Research Laboratories Philippines
 
112-6721049-0/1/1 03-May-2005 66VCY99 3002807504 Merck Sante s.a.s France
 
112-6413331-5/1/1 06-May-2005 66VCY99 3004909700 Medix S.A Mexico
 
112-6626740-0/1/1 11-May-2005 66VCY99 3002806761 Chemical Works of Gedeon Richter PLC. Budapest Site Hungary
 
112-6879037-5/1/1 20-May-2005 66VCY99 3002945792 Interphil Lab Inc Philippines
 
DO7-0092390-0/1/1 18-May-2005 66VDA99 3005029956 Torrent Pharmaceuticals Ltd. India
 
AYB-2151832-9/1/1/C 23-May-2005 66VDK99 3004036224 Sanofi Synthelado Phils Philippines
 
656-1007506-4/1/1 03-May-2005 66VDY99 3004847396 Iar Labs India
 
WUG-0127282-1/30/1 27-May-2005 66VDY99 1000282433 Zandu Pharamceutical Works Ltd India
 
112-6932853-0/1/1 24-May-2005 66VIA99 3004402946 Patheon Canada
 
112-6276311-3/1/1 18-May-2005 66VIB99 3005020939 Genta Inc United States
 
112-6270888-6/1/7 05-May-2005 66VIP99 3005019873 Sacb Mexico
 
112-6439900-7/1/1 24-May-2005 66VIP99 3003687374 Dr. Ken Bayly Canada
 
506-0812169-0/1/1 03-May-2005 66VIY99 3003506949 Polfa Sa Poland
 
112-6215597-1/1/1 04-May-2005 66VIY99 3003236027 Gran'S Remedies Ltd New Zealand
 
940-0162792-9/1/1 13-May-2005 66YDA99 3005011906 Health And Food Products Canada
 
AK9-0021162-9/1/1 03-May-2005 66YDE99 3002156927 Arkopharma Lab France
 
AK9-0021162-9/1/2 03-May-2005 66YDE99 3002156927 Arkopharma Lab France
 
581-6008058-4/1/1/A 02-May-2005 66YDY99 3004136167 Hangzhou FST Pharmaceutical Company Ltd China
 
112-6585803-5/1/1 11-May-2005 66YIP99 3005065274 Dr Nature Italy
 
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