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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
112-7422873-7/1/1 26-Apr-2012 66BAY44 3008334915 Ahn Biotechnologie Germany
 
AEK-8682072-3/1/1 14-Apr-2012 66BBL44 3008753212 Cosonic Electronic China
 
BOS-0038351-6/17/1 30-Apr-2012 66BBY99 3009407408 Nartex Laboratorios Homeopaticos S.A. de C.V. Mexico
 
AEK-8641661-3/1/1 14-Apr-2012 66BDL44 3008295323 Cosonic Electronics Co Ltd China
 
112-6388175-2/1/1 25-Apr-2012 66FCA05 3000597291 Laboratorios De Aplicaciones Medicas, S.A. Dominican Republic
 
112-6727369-1/1/1 25-Apr-2012 66FIA05 3009449447 Metabolex Inc. United States
 
AEK-0109178-0/1/1 05-Apr-2012 66JCA99 3006181452 Universal Drug Ser Canada
 
AEK-0109180-6/1/1 05-Apr-2012 66JCA99 3006181452 Universal Drug Ser Canada
 
AEK-0109181-4/1/1 05-Apr-2012 66JCA99 3006181452 Universal Drug Ser Canada
 
AEK-0109182-2/1/1 05-Apr-2012 66JCA99 3006181452 Universal Drug Ser Canada
 
AEK-0109185-5/1/1 05-Apr-2012 66JCA99 3006181452 Universal Drug Ser Canada
 
AEK-0109188-9/1/1 05-Apr-2012 66JCA99 3006181452 Universal Drug Ser Canada
 
AEK-0109191-3/1/1 05-Apr-2012 66JCA99 3006181452 Universal Drug Ser Canada
 
UPS-5915848-1/1/1 05-Apr-2012 66JCY01 3009472175 B.J. Tworzyanski Limited Canada
 
112-6885156-0/1/1 25-Apr-2012 66JQA01 3003241097 Abbott Canada
 
112-6697821-7/2/1 05-Apr-2012 66MCA36 3005125301 Reliance Formulation Pvt.Ltd India
 
112-9036914-3/1/1 26-Apr-2012 66MCA78 3002906944 Apotex Inc. Canada
 
112-6368307-5/1/1 13-Apr-2012 66MIY83 3002807904 Pliva Hrvatska D.O.O. Croatia
 
XXX-0177610-9/1/2 09-Apr-2012 66N06 3005029956 Torrent Pharmaceuticals Ltd. India
 
112-9228724-4/1/4 26-Apr-2012 66NCA07 3003157498 Intas Pharmaceuticals Limited India
 
F57-6124073-1/6/1 26-Apr-2012 66PAJ99 3004979511 Spaulding Service Center United States
 
F57-6124073-1/8/1 26-Apr-2012 66PAJ99 3004979511 Spaulding Service Center United States
 
UPS-5745686-1/7/1 03-Apr-2012 66PBJ99 3009447751 Valkoinen Risti-Vita Korset Finland
 
112-6518122-7/1/9 20-Apr-2012 66PBL99 3009428339 Doctor Duve Medical Skin Care Germany
 
112-7021467-4/1/1 25-Apr-2012 66PBU99 3009482083 Olivenz New Zealand
 
BBH-3015164-7/12/1 26-Apr-2012 66PBY99 3004961400 Alcare / The House Of Aloes South Africa
 
BBH-3015164-7/11/1 26-Apr-2012 66PBY99 3004961400 Alcare / The House Of Aloes South Africa
 
BBH-3015164-7/10/1 26-Apr-2012 66PBY99 3004961400 Alcare / The House Of Aloes South Africa
 
112-9228724-4/1/6 26-Apr-2012 66SCA27 3008562526 G D Gupta India
 
112-6836679-1/1/2 30-Apr-2012 66SCA27 3008094605 Lloyd Laboratories Inc. Philippines
 
112-6836679-1/1/4 30-Apr-2012 66SCA27 3008094605 Lloyd Laboratories Inc. Philippines
 
112-0683615-2/1/1 26-Apr-2012 66SCB27 3001443914 Bayer Inc Canada
 
XXX-0281671-9/1/3 02-Apr-2012 66SCY27 3004196193 Unique Pharmaceutical Laboratories (Div of JB Chem and Pharm India
 
UPS-5734707-8/1/1 23-Apr-2012 66SCY51 3009466056 C.T.V. Vancouver Canada
 
112-0036321-1/1/1 26-Apr-2012 66SDA51 3008659748 Spimaco Pharmaceuticals Saudi Arabia
 
E7E-1026048-2/4/16 06-Apr-2012 66SDJ28 3008382249 Savage Labs United States
 
112-6807586-3/1/1 25-Apr-2012 66TCC01 3009390965 Glaxo Smithkline Mexico
 
KM6-0121297-0/8/1 02-Apr-2012 66V99 3004120038 Ruchi Worldwide Soy Industries Limited India
 
KM6-0121297-0/8/3 02-Apr-2012 66V99 3004120038 Ruchi Worldwide Soy Industries Limited India
 
FP8-2120270-1/5/1 13-Apr-2012 66V99 3009245426 Metabolic Therapy Mexico
 
E94-1124772-5/2/1 20-Apr-2012 66V99 3004168160 B&J Supplies United Kingdom
 
F57-9000608-7/2/1 04-Apr-2012 66VAJ99 3004737602 Willard Manufacturing Inc. Canada
 
F57-9000608-7/11/1 04-Apr-2012 66VAJ99 3004737602 Willard Manufacturing Inc. Canada
 
F57-9001784-5/8/1 13-Apr-2012 66VAJ99 3004737602 Willard Manufacturing Inc. Canada
 
F57-6124073-1/4/1 26-Apr-2012 66VAJ99 3005133042 Englewood Lab, LLC United States
 
GJ8-0087243-5/5/1/A 12-Apr-2012 66VAL99 3008332645 The Face Shop Korea Co., Ltd Korea, Republic Of (South)
 
GJ8-0087243-5/5/1/C 12-Apr-2012 66VAL99 3008332645 The Face Shop Korea Co., Ltd Korea, Republic Of (South)
 
EK4-0508404-8/10/3 18-Apr-2012 66VAO99 3008963956 Cederroth Polska Sa Poland
 
EK4-0508404-8/12/1 18-Apr-2012 66VAO99 3008963956 Cederroth Polska Sa Poland
 
EK4-0508404-8/13/3 18-Apr-2012 66VAO99 3009195547 Komplex-Torus Sp Zoo Poland
 
629-0024050-8/4/1 17-Apr-2012 66VAY99 3004341688 P.A. Benjamin Manufacturing Co., Ltd. Jamaica
 
AEK-8398922-4/1/2 27-Apr-2012 66VBF99 3007483713 Hootone Remedies India
 
AEK-8398922-4/1/1 27-Apr-2012 66VBF99 3007483713 Hootone Remedies India
 
AEK-8398922-4/1/4 27-Apr-2012 66VBF99 3007483713 Hootone Remedies India
 
AEK-8398922-4/1/3 27-Apr-2012 66VBF99 3007483713 Hootone Remedies India
 
112-6115490-5/1/1 02-Apr-2012 66VBJ99 3008855267 Telesky Shopping P India
 
144-5267849-6/22/11 06-Apr-2012 66VBJ99 3003629010 Eau Zone Huiles Et Fragrances Ltee Canada
 
112-6349581-9/1/1 13-Apr-2012 66VBJ99 3007797153 Kunnath Pharmaceticals India
 
112-6368292-9/1/1 13-Apr-2012 66VBJ99 3007797153 Kunnath Pharmaceticals India
 
144-5361389-8/12/1/A 16-Apr-2012 66VBJ99 3003629010 Eau Zone Huiles Et Fragrances Ltee Canada
 
112-6347243-8/1/1 20-Apr-2012 66VBJ99 3009411592 Ricky Fuchs United Kingdom
 
BZJ-1072983-6/2/1 23-Apr-2012 66VBJ99 3005673616 Bioptik Technology Taiwan
 
BZJ-1072983-6/5/1 23-Apr-2012 66VBJ99 3005673616 Bioptik Technology Taiwan
 
112-6486383-3/1/1/A 25-Apr-2012 66VBJ99 3009208389 P&T Siam Co Ltd Thailand
 
112-6486383-3/1/2/B 25-Apr-2012 66VBJ99 3009208389 P&T Siam Co Ltd Thailand
 
112-6486383-3/1/1/B 25-Apr-2012 66VBJ99 3009208389 P&T Siam Co Ltd Thailand
 
112-6486383-3/1/3 25-Apr-2012 66VBJ99 3009426376 Ma Maison Nature Co Ltd Thailand
 
112-6486383-3/2/1 25-Apr-2012 66VBJ99 3004511012 Kiatthavee Enterprise Thailand
 
112-6486383-3/2/2 25-Apr-2012 66VBJ99 3004511012 Kiatthavee Enterprise Thailand
 
112-6486383-3/2/3 25-Apr-2012 66VBJ99 3009426378 World Wide Agent Universe Beauty Thailand
 
112-6486383-3/2/4 25-Apr-2012 66VBJ99 3009426378 World Wide Agent Universe Beauty Thailand
 
112-6486383-3/2/5 25-Apr-2012 66VBJ99 3009426377 Nanomed Co.,Ltd. Thailand
 
MH9-0100913-3/2/1 02-Apr-2012 66VBY99 3008471426 Berioska, S.L. Spain
 
MH9-0100913-3/2/7 02-Apr-2012 66VBY99 3008471426 Berioska, S.L. Spain
 
MH9-0100913-3/2/9 02-Apr-2012 66VBY99 3008471426 Berioska, S.L. Spain
 
MH9-0100913-3/6/1 02-Apr-2012 66VBY99 3008471426 Berioska, S.L. Spain
 
KM6-0056074-2/10/1 04-Apr-2012 66VBY99 3008885463 JAJU AGRO INDUSTRIES PVT LTD India
 
AMS-0001240-0/26/1 10-Apr-2012 66VBY99 3000243864 Clarins France
 
AMS-0001240-0/39/1 10-Apr-2012 66VBY99 3000243864 Clarins France
 
BBH-3015164-7/2/1 26-Apr-2012 66VBY99 3004961400 Alcare / The House Of Aloes South Africa
 
BBH-3015164-7/13/1 26-Apr-2012 66VBY99 3004961400 Alcare / The House Of Aloes South Africa
 
BBH-3015164-7/9/1 26-Apr-2012 66VBY99 3004961400 Alcare / The House Of Aloes South Africa
 
BBH-3015164-7/8/1 26-Apr-2012 66VBY99 3004961400 Alcare / The House Of Aloes South Africa
 
BBH-3015164-7/7/1 26-Apr-2012 66VBY99 3004961400 Alcare / The House Of Aloes South Africa
 
BBH-3015164-7/6/1 26-Apr-2012 66VBY99 3004961400 Alcare / The House Of Aloes South Africa
 
BBH-3015164-7/5/1 26-Apr-2012 66VBY99 3004961400 Alcare / The House Of Aloes South Africa
 
BBH-3015164-7/4/1 26-Apr-2012 66VBY99 3004961400 Alcare / The House Of Aloes South Africa
 
BBH-3015164-7/3/1 26-Apr-2012 66VBY99 3004961400 Alcare / The House Of Aloes South Africa
 
112-2950157-7/1/2 26-Apr-2012 66VCA99 3005634568 Unicure Remedies Pvt Ltd India
 
112-2950157-7/1/6 26-Apr-2012 66VCA99 3009000030 Ranbaxy Pharma India
 
UPS-5896017-6/1/1 27-Apr-2012 66VCA99 3004078138 Merck S.A. Colombia
 
GJ8-0087243-5/1/6/D 12-Apr-2012 66VCI99 3008332645 The Face Shop Korea Co., Ltd Korea, Republic Of (South)
 
UPS-6445475-7/3/1 09-Apr-2012 66VCK99 3004424699 Herbal Homeopathic (Pty) Ltd. South Africa
 
UPS-5994239-7/1/1 17-Apr-2012 66VCK99 3002286563 Ropsohn Therapeutics Ltda. Colombia
 
112-7038099-6/1/1 27-Apr-2012 66VCP99 3004110157 Patheon Italia S.P.A. Italy
 
UPS-5615754-4/1/1 05-Apr-2012 66VCR99 3009213684 Sha Zuochung Industries & Trade Co. China
 
U47-0489482-1/4/1 03-Apr-2012 66VCS99 3002807336 Janssen Pharmaceutica, N.V. Belgium
 
WBA-9113318-0/1/1 11-Apr-2012 66VCS99 3008237978 Yixing City Xinxin Pearlescent Co., LTD, China
 
UPS-5957195-6/1/1 27-Apr-2012 66VCS99 1000461726 Vitorgan Arzneimittel Gmbh Germany
 
UPS-5994239-7/1/5 17-Apr-2012 66VCY99 3009490375 Janeth Rengifo Colombia
 
W24-0310090-2/1/1/C 17-Apr-2012 66VCY99 3005863504 Rodial United Kingdom
 
W24-0310090-2/1/1/B 17-Apr-2012 66VCY99 3005863504 Rodial United Kingdom
 
071-0190862-7/5/10 05-Apr-2012 66VDA99 3005697855 Sanofi Synthelabo Sp. z.o.o. Poland
 
071-0190862-7/6/10 05-Apr-2012 66VDA99 3004624702 Poznanskie Zaklady Zielarskie Herbapol Sa Poland
 
071-0190862-7/6/13 05-Apr-2012 66VDA99 3004624702 Poznanskie Zaklady Zielarskie Herbapol Sa Poland
 
GJ8-0087243-5/1/2/C 12-Apr-2012 66VDI99 3008332645 The Face Shop Korea Co., Ltd Korea, Republic Of (South)
 
EAA-0002346-7/1/1 03-Apr-2012 66VDK99 3009315403 Genic Co., Ltd. Korea, Republic Of (South)
 
112-2908858-3/3/1 26-Apr-2012 66VDK99 3008995190 Pharmacy Herrera Mexico
 
AMS-0001212-9/32/1 10-Apr-2012 66VDL99 3000243864 Clarins France
 
AMS-0001212-9/33/1/A 10-Apr-2012 66VDL99 3000243864 Clarins France
 
AMS-0001212-9/33/1/B 10-Apr-2012 66VDL99 3000243864 Clarins France
 
AMS-0001212-9/59/1 10-Apr-2012 66VDL99 3000243864 Clarins France
 
AMS-0001212-9/60/1 10-Apr-2012 66VDL99 3000243864 Clarins France
 
AMS-0001212-9/62/1 10-Apr-2012 66VDL99 3000243864 Clarins France
 
AMS-0001212-9/67/1 10-Apr-2012 66VDL99 3000243864 Clarins France
 
AMS-0001212-9/69/1 10-Apr-2012 66VDL99 3000243864 Clarins France
 
AMS-0001212-9/72/1 10-Apr-2012 66VDL99 3000243864 Clarins France
 
AMS-0001212-9/75/1 10-Apr-2012 66VDL99 3000243864 Clarins France
 
AMS-0001212-9/77/1 10-Apr-2012 66VDL99 3000243864 Clarins France
 
AMS-0001212-9/92/1 10-Apr-2012 66VDL99 3000243864 Clarins France
 
AMS-0001212-9/93/1 10-Apr-2012 66VDL99 3000243864 Clarins France
 
BSF-0015992-9/13/1/A 02-Apr-2012 66VDY99 3009316423 Lab Dr Collado Dominican Republic
 
BSF-0015992-9/13/1/B 02-Apr-2012 66VDY99 3009316423 Lab Dr Collado Dominican Republic
 
XXX-0281681-8/1/1 02-Apr-2012 66VDY99 3002806504 Biologische Heilmittel Heel Gmbh Germany
 
XXX-0281681-8/1/2 02-Apr-2012 66VDY99 3002806504 Biologische Heilmittel Heel Gmbh Germany
 
XXX-0281681-8/1/3 02-Apr-2012 66VDY99 3002806504 Biologische Heilmittel Heel Gmbh Germany
 
XXX-0281681-8/1/4 02-Apr-2012 66VDY99 3002806504 Biologische Heilmittel Heel Gmbh Germany
 
XXX-0281681-8/1/5 02-Apr-2012 66VDY99 3002806504 Biologische Heilmittel Heel Gmbh Germany
 
XXX-0281681-8/1/6 02-Apr-2012 66VDY99 3002806504 Biologische Heilmittel Heel Gmbh Germany
 
XXX-0281681-8/1/7 02-Apr-2012 66VDY99 3002806504 Biologische Heilmittel Heel Gmbh Germany
 
XXX-0281681-8/1/8 02-Apr-2012 66VDY99 3002806504 Biologische Heilmittel Heel Gmbh Germany
 
544-0108457-6/2/1 03-Apr-2012 66VDY99 3009436276 Loren Beautifiers Pvt. Ltd India
 
544-0108457-6/3/1 03-Apr-2012 66VDY99 2000010253 Medipal-Onco Russia
 
D79-0017796-6/5/3 06-Apr-2012 66VDY99 3003654399 Phytolab SL Spain
 
D79-0017796-6/5/4 06-Apr-2012 66VDY99 3003654399 Phytolab SL Spain
 
D79-0017796-6/5/7 06-Apr-2012 66VDY99 3003654399 Phytolab SL Spain
 
D97-0635527-5/12/1/B 13-Apr-2012 66VDY99 1000131550 Parfums Christian Dior France
 
D97-0635527-5/20/1/A 13-Apr-2012 66VDY99 1000131550 Parfums Christian Dior France
 
D97-0635527-5/20/1/B 13-Apr-2012 66VDY99 1000131550 Parfums Christian Dior France
 
D97-0635527-5/20/1/C 13-Apr-2012 66VDY99 1000131550 Parfums Christian Dior France
 
D97-0635527-5/20/1/D 13-Apr-2012 66VDY99 1000131550 Parfums Christian Dior France
 
D97-0635527-5/21/1 13-Apr-2012 66VDY99 1000131550 Parfums Christian Dior France
 
EHP-0074782-5/1/1 16-Apr-2012 66VDY99 3008791728 Shinkoh Communication Industry Co Ltd Japan
 
UPS-5637619-3/1/1 16-Apr-2012 66VDY99 3009452337 Mr H P Sharma India
 
UPS-5637619-3/1/3 16-Apr-2012 66VDY99 3009452337 Mr H P Sharma India
 
UPS-5637619-3/1/2 16-Apr-2012 66VDY99 3009452337 Mr H P Sharma India
 
UPS-5637619-3/1/5 16-Apr-2012 66VDY99 3009452337 Mr H P Sharma India
 
UPS-5637619-3/1/4 16-Apr-2012 66VDY99 3009452337 Mr H P Sharma India
 
AMS-0001949-6/260/1 27-Apr-2012 66VDY99 3000243864 Clarins France
 
AMS-0001949-6/261/1 27-Apr-2012 66VDY99 3000243864 Clarins France
 
AMS-0001949-6/262/1 27-Apr-2012 66VDY99 3000243864 Clarins France
 
AMS-0001949-6/263/1 27-Apr-2012 66VDY99 3000243864 Clarins France
 
AMS-0001949-6/265/1 27-Apr-2012 66VDY99 3008964045 Clarins France
 
300-3658736-6/1/1 04-Apr-2012 66VIL99 3004063541 Biovectra, Inc. Canada
 
112-8393275-8/1/1 06-Apr-2012 66VIP99 1000206559 Takeda Pharmaceutical Co, Ltd Japan
 
UPS-5554351-2/1/1 13-Apr-2012 66VIY99 3008299086 Veronika Pollard United Kingdom
 
906-2133212-2/1/1 06-Apr-2012 66VPJ99 3009425983 Anderson & Morkel Cc T/A Venster South Africa
 
UPS-5950049-2/1/1 23-Apr-2012 66YAS99 3009477668 Avanztec Inc Canada
 
U47-0488648-8/1/1/A 03-Apr-2012 66YCY99 3008957760 Chinoin Limited Hungary
 
U47-0488648-8/1/1/B 03-Apr-2012 66YCY99 3008957760 Chinoin Limited Hungary
 
U47-0488648-8/1/1/C 03-Apr-2012 66YCY99 3008957760 Chinoin Limited Hungary
 
BUP-1538937-5/1/1 23-Apr-2012 66YIY99 3009153372 Novasep Process Belgium
 
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