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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
112-1578783-9/1/1 03-Dec-2003 66BAA19 3003646846 Sdx Netherlands
 
112-1579108-8/1/1 03-Dec-2003 66BAA19 3003646846 Sdx Netherlands
 
XXX-0073579-6/1/1 15-Dec-2003 66BAF99 3004198681 Lila Feitoza Brazil
 
AEK-6275414-4/1/1 23-Dec-2003 66BDA19 3004173292 Manop Phongmekin Thailand
 
112-2039729-3/2/1/A 23-Dec-2003 66CAY99 3002128313 SANUM-Kehlbeck GmbH & Co. KG Germany
 
112-1655261-2/1/1/D 18-Dec-2003 66FCA05 1000219714 Alphagen Laboratories Inc United States
 
112-1517021-8/1/1/A 05-Dec-2003 66JCP01 3004140129 Dpharma Mexico
 
112-1601848-1/1/1 18-Dec-2003 66MBB75 3004150916 Dulcinea Alves Da Silva Brazil
 
112-1655261-2/1/1/A 18-Dec-2003 66MCA83 3003232466 Sidmark Laboratories Inc. United States
 
112-1655261-2/1/1/B 18-Dec-2003 66MCA83 2024830 Watson Laboratories Inc United States
 
112-2052951-5/1/1 23-Dec-2003 66MCY78 3004207240 Egis Gyogyszertar Rt Hungary
 
P09-3035613-7/10/1 30-Dec-2003 66PBR99 3004046514 Cosnecor Ltd Japan
 
P09-3035613-7/10/2 30-Dec-2003 66PBR99 3004046514 Cosnecor Ltd Japan
 
P09-3035613-7/10/3 30-Dec-2003 66PBR99 3004046514 Cosnecor Ltd Japan
 
582-6593190-7/1/1 19-Dec-2003 66PBY99 3004359868 Dr. Hauschka Losmetik Germany
 
AEK-6289563-2/1/1 30-Dec-2003 66PBY99 3004198372 Tanning Research Labs Inc United States
 
862-0177248-9/4/1 22-Dec-2003 66RBK99 3002808072 Santen Pharm. Co., Ltd. Japan
 
112-1914247-8/1/2 17-Dec-2003 66SCA27 3004190911 S Leyland Canada
 
112-1579472-8/1/1 03-Dec-2003 66SCA99 3003452191 Special Delivery Exchange Netherlands
 
112-1580012-9/1/1 03-Dec-2003 66SCA99 3003646846 Sdx Netherlands
 
112-1580015-2/1/1 03-Dec-2003 66SCA99 3003646846 Sdx Netherlands
 
112-1599831-1/1/1 03-Dec-2003 66SCA99 3003646846 Sdx Netherlands
 
112-1599938-4/1/1 03-Dec-2003 66SCA99 3003646846 Sdx Netherlands
 
112-1600446-5/1/1 03-Dec-2003 66SCA99 3003646846 Sdx Netherlands
 
112-1600490-3/1/1 03-Dec-2003 66SCA99 3003646846 Sdx Netherlands
 
112-1600703-9/1/1 03-Dec-2003 66SCA99 3004150772 Sdx Netherlands
 
112-2006303-6/1/1 05-Dec-2003 66SCY03 3004202178 Somsong Thailand
 
112-2028121-6/1/1 16-Dec-2003 66SIP45 3004204624 Eminent Management United Kingdom
 
310-9136533-3/1/1/E 24-Dec-2003 66V99 3000145813 Dolisos Canada Canada
 
310-9136533-3/1/1/F 24-Dec-2003 66V99 1000261402 Laboratoires Boiron France
 
HE8-0056336-4/1/14 29-Dec-2003 66VAJ99 1000577226 Coreana Cosmetics Co Korea, Republic Of (South)
 
C47-0177813-5/1/1 03-Dec-2003 66VAL99 3003808437 Agences Pehacheve Haiti
 
WIB-1178293-8/1/1/A 17-Dec-2003 66VAL99 3003655747 Bio Oaky Co. Ltd Korea, Republic Of (South)
 
WIB-1178293-8/1/1/B 17-Dec-2003 66VAL99 3003655747 Bio Oaky Co. Ltd Korea, Republic Of (South)
 
D05-0206858-4/1/12 19-Dec-2003 66VAL99 3002931289 Alain Ganancia S.L. Spain
 
D05-0206858-4/1/10 19-Dec-2003 66VAL99 3002931289 Alain Ganancia S.L. Spain
 
D05-0206858-4/1/11 19-Dec-2003 66VAL99 3002931289 Alain Ganancia S.L. Spain
 
D05-0206858-4/1/9 19-Dec-2003 66VAL99 3002931289 Alain Ganancia S.L. Spain
 
GL5-0698221-1/1/1 29-Dec-2003 66VAR99 3003781796 Mr. Uthai Lokavee Thailand
 
112-1608708-0/1/1 03-Dec-2003 66VAY99 3003183014 Mrw Venezuela
 
112-1656220-7/1/1 18-Dec-2003 66VAY99 3004157365 Hritik Chemical Co India
 
112-1586959-5/1/1 18-Dec-2003 66VAY99 3004003797 Service Express Fe Venezuela
 
112-1774617-1/1/1 18-Dec-2003 66VAY99 3004173627 Tyn-Jam Intl Co Ltd Taiwan
 
112-1791928-1/1/1 18-Dec-2003 66VAY99 3004155006 Trimax Express Ser India
 
D05-0206858-4/1/8 19-Dec-2003 66VAY99 3002931289 Alain Ganancia S.L. Spain
 
D05-0206858-4/1/7 19-Dec-2003 66VAY99 3002931289 Alain Ganancia S.L. Spain
 
D05-0206858-4/1/3 19-Dec-2003 66VAY99 3002931289 Alain Ganancia S.L. Spain
 
AP4-0035077-7/2/1 24-Dec-2003 66VAY99 3003857201 Pak Best Group Pakistan
 
XXX-0072208-3/1/1 16-Dec-2003 66VBB99 3004176523 KLINOS C.A. Venezuela
 
XXX-0072208-3/1/2 16-Dec-2003 66VBB99 3004176553 Pharmacia Corporation de Venezuela Venezuela
 
112-1635602-2/1/1 18-Dec-2003 66VBB99 3004155007 Vikram A Patel India
 
C47-0177813-5/1/4 03-Dec-2003 66VBJ99 3004132466 LABORATORIO CHEVALIER Dominican Republic
 
112-1397063-5/1/1 05-Dec-2003 66VBJ99 3004124914 Genmar Cosmetics S Romania
 
AGT-0000538-0/4/1/B 10-Dec-2003 66VBJ99 3003688127 Insaaniyya Herbal Drug Centre Ghana
 
AGT-0000538-0/4/1/C 10-Dec-2003 66VBJ99 3004144638 BELTAPHARM S.p.A. Italy
 
AGT-0000538-0/4/1/A 10-Dec-2003 66VBJ99 3003654720 SIVOP Ivory Coast
 
GL5-0698221-1/10/1 29-Dec-2003 66VBJ99 3003781796 Mr. Uthai Lokavee Thailand
 
HD8-0066249-0/1/18 29-Dec-2003 66VBJ99 1000324479 Lg International Korea, Republic Of (South)
 
C47-0177813-5/1/2 03-Dec-2003 66VBL99 3004132410 FAB LAURYL LAB. Haiti
 
C47-0177813-5/1/3 03-Dec-2003 66VBL99 3004132410 FAB LAURYL LAB. Haiti
 
C47-0177813-5/1/5 03-Dec-2003 66VBL99 3004132585 unkown Haiti
 
C47-0177813-5/1/6 03-Dec-2003 66VBL99 3004132585 unkown Haiti
 
C47-0177813-5/1/7 03-Dec-2003 66VBR99 3004132617 Laboratoratorios Dr. Collado,C and A. Dominican Republic
 
C47-0177813-5/1/8 03-Dec-2003 66VBR99 3004132633 NOVARTIS Colombia
 
U29-0160610-5/110/1 30-Dec-2003 66VBR99 3003639262 Kaiser Pharmaceutical Co. Taiwan
 
U29-0160610-5/137/1 30-Dec-2003 66VBR99 3003639262 Kaiser Pharmaceutical Co. Taiwan
 
AQZ-0196031-2/1/1 08-Dec-2003 66VBY99 3004179541 Klosterfraumaria Clementine Martin Germany
 
AQZ-0196031-2/2/1 08-Dec-2003 66VBY99 3004179541 Klosterfraumaria Clementine Martin Germany
 
AGT-0000538-0/3/1/B 10-Dec-2003 66VBY99 3003654720 SIVOP Ivory Coast
 
W69-1166899-5/1/2 10-Dec-2003 66VBY99 3003333514 China Shaanxi Xinxin Trading Co Ltd China
 
582-7201702-1/1/1 16-Dec-2003 66VBY99 3004184469 Daesung Bio Co Korea, Republic Of (South)
 
582-7201699-9/1/1 16-Dec-2003 66VBY99 3004184469 Daesung Bio Co Korea, Republic Of (South)
 
582-7201695-7/1/1 16-Dec-2003 66VBY99 3004184469 Daesung Bio Co Korea, Republic Of (South)
 
582-5805146-5/1/1 23-Dec-2003 66VBY99 3003966635 Feel Good Health South Africa
 
582-5805146-5/1/5 23-Dec-2003 66VBY99 3003966635 Feel Good Health South Africa
 
582-5797749-6/1/1 23-Dec-2003 66VBY99 3003966635 Feel Good Health South Africa
 
582-5797749-6/1/2 23-Dec-2003 66VBY99 3003966635 Feel Good Health South Africa
 
D77-0130527-9/6/1 24-Dec-2003 66VBY99 3002665859 Tokyo Plast International Ltd. India
 
ES2-0021432-9/1/1 24-Dec-2003 66VBY99 3004090094 Langfang Triple Well Chemicals Co.,Ltd China
 
ES2-0021432-9/1/2 24-Dec-2003 66VBY99 3004090094 Langfang Triple Well Chemicals Co.,Ltd China
 
FS2-1035392-6/7/1 29-Dec-2003 66VBY99 3001600220 Theodor Jebe Gmbh Germany
 
FS2-1035392-6/7/2 29-Dec-2003 66VBY99 3001600220 Theodor Jebe Gmbh Germany
 
FS2-1035392-6/7/3 29-Dec-2003 66VBY99 3001600220 Theodor Jebe Gmbh Germany
 
FS2-1035392-6/7/4 29-Dec-2003 66VBY99 3001600220 Theodor Jebe Gmbh Germany
 
FS2-1035392-6/7/5 29-Dec-2003 66VBY99 3001600220 Theodor Jebe Gmbh Germany
 
FS2-1035392-6/7/6 29-Dec-2003 66VBY99 3001600220 Theodor Jebe Gmbh Germany
 
GL5-0698221-1/5/1 29-Dec-2003 66VBY99 3003781796 Mr. Uthai Lokavee Thailand
 
HK1-0136680-3/1/19 29-Dec-2003 66VBY99 3002920197 Lee Fung Heng Hong Kong SAR
 
HK1-0136680-3/1/24 29-Dec-2003 66VBY99 3002920197 Lee Fung Heng Hong Kong SAR
 
N95-1034229-4/2/1/G 30-Dec-2003 66VBY99 3005699922 Jagal Pharma Limited Nigeria
 
N95-1034229-4/2/1/H 30-Dec-2003 66VBY99 3003328259 Pz Nigeria Limited Nigeria
 
ND7-0011787-9/1/1 30-Dec-2003 66VBY99 3003588290 Nature'S Bounty (Nbty) United States
 
XXX-0072191-1/1/1 16-Dec-2003 66VCF99 3004176187 LABORATORIOS HORMONA,S.A.de C.V. Mexico
 
XXX-0072207-5/1/1 16-Dec-2003 66VCF99 3004176363 Bristol-Myers Squibb S.P.A. Italy
 
XXX-0072207-5/1/2 16-Dec-2003 66VCF99 3004176363 Bristol-Myers Squibb S.P.A. Italy
 
XXX-0072207-5/1/3 16-Dec-2003 66VCF99 3004176432 GlaxoSmithKline France
 
112-2016867-8/1/1 16-Dec-2003 66VCK99 3004203371 Dr Nicolas Lopez Mexico
 
112-2020076-0/1/1 16-Dec-2003 66VCL99 3004204496 Flora Germany
 
112-1675131-3/1/1 18-Dec-2003 66VCO99 3003990050 Emmessar Biotech India
 
112-1420701-1/1/1 02-Dec-2003 66VCP99 3003943458 Franpostal Ltda Colombia
 
112-1490997-0/1/1 03-Dec-2003 66VCP99 3004137695 Annemarie Michell Australia
 
112-1533825-2/1/1 03-Dec-2003 66VCP99 3004142059 Westwood Hills Vet Canada
 
112-1578946-2/1/1 03-Dec-2003 66VCP99 3003646846 Sdx Netherlands
 
112-0662795-2/1/1 05-Dec-2003 66VCP99 3004011157 Servientrega Inter Colombia
 
112-0750295-6/1/1 05-Dec-2003 66VCP99 3004034790 Farmacia Once Argentina
 
582-3771635-2/1/1 10-Dec-2003 66VCP99 3004216340 Aventis Pharma Deutschland GmbH A. Nattermann & Cie GmbH Germany
 
112-1883299-6/1/1 12-Dec-2003 66VCP99 3003920081 Aerocasillas Sa Panama
 
112-2026898-1/1/1 12-Dec-2003 66VCP99 3004204456 Matteo Cerretelli Italy
 
112-1992860-3/1/1 15-Dec-2003 66VCP99 3004200257 Mother Natures Trinidad & Tobago
 
112-1955167-8/1/1 15-Dec-2003 66VCP99 3004195533 Minerva A Gtz Mexico
 
112-2054036-3/1/1 16-Dec-2003 66VCP99 1000353378 Flughafen Apotheke Germany
 
112-1997798-0/1/1 16-Dec-2003 66VCP99 3003716087 Lasco LTD. Barbados
 
112-2042238-0/1/1 17-Dec-2003 66VCP99 1000353378 Flughafen Apotheke Germany
 
112-1804029-3/1/1 18-Dec-2003 66VCP99 3004177203 Atul Farm India
 
112-2128054-8/1/1 22-Dec-2003 66VCP99 3004215669 Veronique Tarrieu Martinique
 
112-2052951-5/1/2 23-Dec-2003 66VCP99 3004207242 Servier Hungaria Hungary
 
112-2102174-4/1/1 23-Dec-2003 66VCP99 3004212135 Farmacias Del Mundo S.A. Mexico
 
112-2102174-4/1/2 23-Dec-2003 66VCP99 3004212135 Farmacias Del Mundo S.A. Mexico
 
112-2125929-4/1/1/A 17-Dec-2003 66VCY99 3004215471 University Of California France
 
XXX-0076143-8/1/1 18-Dec-2003 66VCY99 3004363169 M. Bedard Canada
 
AP4-0034430-9/20/1 24-Dec-2003 66VCY99 3003857201 Pak Best Group Pakistan
 
112-1959272-2/1/1 16-Dec-2003 66VCZ99 3004196252 Aldo Lambelet Italy
 
XXX-0072207-5/1/4 16-Dec-2003 66VDB99 3004116336 Roche France
 
XXX-0072208-3/1/3 16-Dec-2003 66VDB99 3004176559 A. MENARINI Industrie Sud srl Italy
 
112-2125929-4/1/1/B 17-Dec-2003 66VDB99 3004215471 University Of California France
 
310-9136456-7/1/1 04-Dec-2003 66VDY99 3004191054 Heather Fowler Canada
 
310-9140592-3/1/1/A 12-Dec-2003 66VDY99 3002949366 Baoji Jin Tai Saipu Clothes Factory China
 
310-9140592-3/1/1/B 12-Dec-2003 66VDY99 3002949366 Baoji Jin Tai Saipu Clothes Factory China
 
310-9140592-3/1/1/C 12-Dec-2003 66VDY99 3002949366 Baoji Jin Tai Saipu Clothes Factory China
 
310-9140592-3/1/1/D 12-Dec-2003 66VDY99 3002949366 Baoji Jin Tai Saipu Clothes Factory China
 
310-9140592-3/1/1/E 12-Dec-2003 66VDY99 3002949366 Baoji Jin Tai Saipu Clothes Factory China
 
310-9140592-3/1/1/F 12-Dec-2003 66VDY99 3002949366 Baoji Jin Tai Saipu Clothes Factory China
 
112-2081294-5/1/1 17-Dec-2003 66VDY99 3004210376 Zhen Chang-Lin Canada
 
310-9136463-3/1/1/A 23-Dec-2003 66VDY99 3004191055 Catherine Daigle Canada
 
310-9136862-6/1/1 23-Dec-2003 66VDY99 3002862006 Catalyitca Pharmaceuticals United States
 
310-9136861-8/1/1 23-Dec-2003 66VDY99 3002664697 Canadian Natural Canada
 
310-9136859-2/1/1 23-Dec-2003 66VDY99 3004195757 Jacklyn Mercer Canada
 
310-9136566-3/1/1 23-Dec-2003 66VDY99 3004192133 Blerworth Jh Canada
 
310-9136461-7/1/1 23-Dec-2003 66VDY99 3004191111 Bill Nadeau Canada
 
310-9136458-3/1/1 23-Dec-2003 66VDY99 3001748040 SCHERING CANADA INC. Canada
 
AEK-6266198-4/1/1 23-Dec-2003 66VDY99 3004154112 Willi Rupprecht Germany
 
310-9136569-7/1/1 23-Dec-2003 66VDY99 3003971524 Performance Marketing Canada
 
310-9136572-1/1/1 23-Dec-2003 66VDY99 3002616705 Novartis Consumer Health Canada, Inc. Canada
 
310-9136571-3/1/1 23-Dec-2003 66VDY99 3004731401 Urban Nutrition Inc United States
 
310-9136867-5/1/1/A 23-Dec-2003 66VDY99 3004196078 Rita Bercan Canada
 
310-9140589-9/1/1/A 29-Dec-2003 66VDY99 3004195839 Wong Wei Yee Sweden
 
310-9140589-9/1/1/B 29-Dec-2003 66VDY99 3004199850 MIWANA AB Sweden
 
310-9140589-9/1/1/C 29-Dec-2003 66VDY99 3004199842 LEUNG WAH MEDICINE CO. Hong Kong SAR
 
310-9140589-9/1/1/D 29-Dec-2003 66VDY99 1000311218 Schering Plough Sweden
 
310-9140589-9/1/1/E 29-Dec-2003 66VDY99 1000311218 Schering Plough Sweden
 
310-9140584-0/1/1/C 29-Dec-2003 66VDY99 3004195761 Freight Express Indonesia
 
310-9140584-0/1/1/D 29-Dec-2003 66VDY99 3004195761 Freight Express Indonesia
 
310-9140584-0/1/1/E 29-Dec-2003 66VDY99 3004195761 Freight Express Indonesia
 
310-9140584-0/1/1/F 29-Dec-2003 66VDY99 3004195761 Freight Express Indonesia
 
310-9136864-2/1/1/B 29-Dec-2003 66VDY99 3004198627 O'TENTIKA PRODUCTS Sweden
 
582-9045240-8/1/1 31-Dec-2003 66VDY99 3004374828 Mercedes Reyes Diaz Mexico
 
XXX-0075545-5/1/1 31-Dec-2003 66VDY99 3003997738 Sally Chow Canada
 
XXX-0075437-5/1/1 31-Dec-2003 66VDY99 3003997738 Sally Chow Canada
 
112-1697044-2/1/2 18-Dec-2003 66VIB99 3002806504 Biologische Heilmittel Heel Gmbh Germany
 
112-2039729-3/2/1/B 23-Dec-2003 66VIK99 3002128313 SANUM-Kehlbeck GmbH & Co. KG Germany
 
112-1697044-2/1/1 18-Dec-2003 66VIL99 3004167717 Pharmacie des Eaux-Vives Mme I. Celardin Switzerland
 
112-2010635-5/1/1 17-Dec-2003 66VOY99 3003951513 Dr F Janeczek Practising Veterin Germany
 
EQ6-0003124-7/51/1 15-Dec-2003 66YAL99 3004668598 Batleys plc United Kingdom
 
112-2214992-4/1/1 22-Dec-2003 66YBL99 3004282657 China Japan Feida Union Co., Ltd. Hong Kong SAR
 
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