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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
144-0945066-8/1/1 17-Nov-2009 66BAL44 3007335074 KINGFOX ENTERPRISES China
 
UPS-5393331-1/1/1 09-Nov-2009 66BAS44 3007697677 Smoking Everywhere Llc Canada
 
XXX-0166018-3/2/1 16-Nov-2009 66BBQ99 3007753159 Liaoshi Technology Co. LTD China
 
AEK-9963879-9/1/1 23-Nov-2009 66BCQ44 3007899388 Gamucci United Kingdom
 
112-9072342-1/1/1 06-Nov-2009 66BIY44 3006989916 Mcneil Consumer Healthcare Canada
 
BAO-0011513-9/1/4 24-Nov-2009 66CAH99 3007857015 Coast Enterprises Sa Panama
 
224-0528171-2/14/1 06-Nov-2009 66FBJ99 3007627404 Shree Kritika Enterprises Nepal
 
551-8396903-4/35/1 03-Nov-2009 66FBL99 1000399435 Homeolab Inc. Canada
 
551-8396903-4/39/1 03-Nov-2009 66FBL99 1000399435 Homeolab Inc. Canada
 
551-8404002-5/24/1 03-Nov-2009 66FBY99 1000399435 Homeolab Inc. Canada
 
551-8404002-5/25/1 03-Nov-2009 66FBY99 1000399435 Homeolab Inc. Canada
 
551-8404002-5/26/1 03-Nov-2009 66FBY99 1000399435 Homeolab Inc. Canada
 
UPS-6533635-4/1/1 24-Nov-2009 66JCY01 3007994285 Bmo Capital Markets Canada
 
XXX-0288811-4/1/1 19-Nov-2009 66MAA03 3006763270 EMS Brazil
 
112-9337572-4/1/1 17-Nov-2009 66MDA03 3005012007 Aristo Pharmaceuticals Ltd India
 
AEK-9958098-3/1/1 09-Nov-2009 66NCA07 3007882846 Krishna Medical India
 
101-8241752-6/1/1 05-Nov-2009 66PBJ99 3007607983 Laboratorios Suizos S.A. De C.V. Brazil
 
101-8241752-6/2/1 05-Nov-2009 66PBJ99 3007607983 Laboratorios Suizos S.A. De C.V. Brazil
 
112-9066460-9/1/1 06-Nov-2009 66PBJ99 1000524645 Northwest Cosmetic Laboratories, LLC United States
 
DP6-0077387-4/1/1/C 23-Nov-2009 66PBJ99 3002512998 Jean D'Arcel Cosmetique Germany
 
DP6-0077387-4/1/1/B 23-Nov-2009 66PBJ99 3002512998 Jean D'Arcel Cosmetique Germany
 
DP6-0077387-4/1/1/A 23-Nov-2009 66PBJ99 3002512998 Jean D'Arcel Cosmetique Germany
 
W98-0147441-7/16/1 25-Nov-2009 66PBJ99 3003981031 A S T France
 
W98-0147441-7/8/1 25-Nov-2009 66PBL99 3003981031 A S T France
 
W98-0147441-7/9/1 25-Nov-2009 66PBL99 3003981031 A S T France
 
W98-0147441-7/10/1/A 25-Nov-2009 66PBL99 3003981031 A S T France
 
101-8241752-6/3/1 05-Nov-2009 66PBY99 3007607983 Laboratorios Suizos S.A. De C.V. Brazil
 
K51-0067415-6/7/1 02-Nov-2009 66VAL99 3007203952 Torbet Laboratories Ltd United Kingdom
 
WUG-0146767-8/1/2 09-Nov-2009 66VAL99 2000024695 Vedic Bio Labs Pvt Ltd India
 
WUG-0146767-8/3/1 09-Nov-2009 66VAL99 2000024695 Vedic Bio Labs Pvt Ltd India
 
AEK-6602696-0/1/1 17-Nov-2009 66VAL99 3007875998 Fratelli Damato Intl Switzerland
 
399-0938538-5/1/1 17-Nov-2009 66VAY99 3006469353 Cinogen Cosmetics (zhaoqing), Ltd. China
 
336-5466884-0/4/1 02-Nov-2009 66VBE99 3003036960 Bio-K Plus International Incorporated Canada
 
K80-0971196-2/1/1/C 03-Nov-2009 66VBJ99 1000192594 Wei Mei Li Chemical Mfg Co Ltd Taiwan
 
224-0528171-2/4/2/C 06-Nov-2009 66VBJ99 3007627404 Shree Kritika Enterprises Nepal
 
224-0528171-2/4/2/D 06-Nov-2009 66VBJ99 3007627404 Shree Kritika Enterprises Nepal
 
SQ4-0048948-1/11/1 16-Nov-2009 66VBJ99 3001549937 Urist Cosmetics Inc Canada
 
112-5048434-5/1/1/A 05-Nov-2009 66VBL99 3005975649 Peter Lyons United Kingdom
 
224-0528171-2/4/2/B 06-Nov-2009 66VBL99 3007627404 Shree Kritika Enterprises Nepal
 
224-0528171-2/16/1 06-Nov-2009 66VBL99 3007627404 Shree Kritika Enterprises Nepal
 
WUG-0146767-8/1/1 09-Nov-2009 66VBL99 2000024695 Vedic Bio Labs Pvt Ltd India
 
277-0122159-3/7/1/A 04-Nov-2009 66VBY99 3007555812 Nguan Heng Chan Tea Thailand
 
DZ1-0396734-2/6/1 18-Nov-2009 66VBY99 3001757812 Lucky Shing Enterprise Co Ltd Vietnam
 
XXX-0169138-6/1/1 23-Nov-2009 66VBY99 3001149270 Pond's Chemical Thailand R.O.P. Thailand
 
XXX-0169138-6/1/2 23-Nov-2009 66VBY99 1000380793 Domesco Vietnam
 
UPS-6205298-8/1/1 10-Nov-2009 66VCA99 3002393800 Ups Tsg Canada
 
XXX-0288798-3/1/1 20-Nov-2009 66VCA99 3007208954 Genfar S.A. Colombia
 
UPS-6180085-8/1/1 09-Nov-2009 66VCC99 3007220093 Munir Khan India
 
UPS-6371583-1/1/1 23-Nov-2009 66VCC99 3007930676 Rahim Bhai India
 
UPS-6371583-1/1/2 23-Nov-2009 66VCC99 3007930676 Rahim Bhai India
 
112-3999936-3/1/1 04-Nov-2009 66VCF99 3004613060 Pasar Express S A Colombia
 
XXX-0288807-2/1/1 19-Nov-2009 66VCH99 3007208954 Genfar S.A. Colombia
 
XXX-0288807-2/1/4 19-Nov-2009 66VCH99 3001399462 F.Hoffman La Roche Ag Switzerland
 
XXX-0288798-3/1/2 20-Nov-2009 66VCK99 3007208954 Genfar S.A. Colombia
 
277-0122988-5/14/1/A 25-Nov-2009 66VCL99 3007178677 B.C. Cosmetic Co.,Ltd. Thailand
 
277-0122988-5/14/1/B 25-Nov-2009 66VCL99 3007178677 B.C. Cosmetic Co.,Ltd. Thailand
 
AEK-6602016-1/1/1 17-Nov-2009 66VCR99 3007861840 Export Solutions Inc Nepal
 
277-0122869-7/4/1/B 04-Nov-2009 66VCY99 3002003042 Twin Lotus Co. Ltd. Thailand
 
XXX-0288807-2/1/2 19-Nov-2009 66VCZ99 3001399462 F.Hoffman La Roche Ag Switzerland
 
XXX-0288798-3/1/3 20-Nov-2009 66VCZ99 3001399462 F.Hoffman La Roche Ag Switzerland
 
112-5683472-5/1/1 02-Nov-2009 66VDA99 3003282644 Sanofi Winthrop Industrie France
 
112-9379938-6/1/4 12-Nov-2009 66VDA99 3007894966 Merck Ltd India
 
112-9379938-6/1/7 12-Nov-2009 66VDA99 3007894968 Remidx Pharma Pvt Ltd India
 
112-9379938-6/1/8 12-Nov-2009 66VDA99 3007894968 Remidx Pharma Pvt Ltd India
 
112-8195125-4/1/1/B 18-Nov-2009 66VDA99 3007674918 Pharmadose Kft Hungary
 
112-8269428-3/1/1 18-Nov-2009 66VDA99 3007687039 Ajmera Pharmaceuticals India
 
112-8269428-3/1/3 18-Nov-2009 66VDE99 3007687041 Herbazalive India
 
K51-0067630-0/1/1 03-Nov-2009 66VDH99 3007418913 Mpt Sudamerica Ecuador
 
112-5415298-9/1/1 03-Nov-2009 66VDJ99 3007225767 Heli-Motors, Gp, C.A Venezuela
 
K80-0971196-2/1/1/B 03-Nov-2009 66VDJ99 1000192594 Wei Mei Li Chemical Mfg Co Ltd Taiwan
 
277-0122159-3/15/1/A 04-Nov-2009 66VDJ99 3007178677 B.C. Cosmetic Co.,Ltd. Thailand
 
277-0122159-3/15/1/B 04-Nov-2009 66VDJ99 3007178677 B.C. Cosmetic Co.,Ltd. Thailand
 
277-0122159-3/17/1/A 04-Nov-2009 66VDJ99 1000411606 Golden Elephant Dispensary Thailand
 
277-0122159-3/17/1/B 04-Nov-2009 66VDJ99 1000411606 Golden Elephant Dispensary Thailand
 
112-8269428-3/1/2 18-Nov-2009 66VDJ99 3007687042 Surya Ayurveda Nilayam India
 
277-0123309-3/18/1/B 20-Nov-2009 66VDJ99 1000411606 Golden Elephant Dispensary Thailand
 
277-0123309-3/18/1/C 20-Nov-2009 66VDJ99 1000411606 Golden Elephant Dispensary Thailand
 
277-0123309-3/18/1/D 20-Nov-2009 66VDJ99 1000411606 Golden Elephant Dispensary Thailand
 
277-0123309-3/18/1/E 20-Nov-2009 66VDJ99 1000411606 Golden Elephant Dispensary Thailand
 
277-0123309-3/18/1/A 20-Nov-2009 66VDJ99 1000411606 Golden Elephant Dispensary Thailand
 
UPS-0770981-2/1/1/D 06-Nov-2009 66VDK99 1000414342 Jenahexal Pharm GmbH Germany
 
UPS-0770981-2/1/1/E 06-Nov-2009 66VDK99 1000414342 Jenahexal Pharm GmbH Germany
 
XXX-0288807-2/1/3 19-Nov-2009 66VDK99 3001399462 F.Hoffman La Roche Ag Switzerland
 
XXX-0288798-3/1/4 20-Nov-2009 66VDK99 3001399462 F.Hoffman La Roche Ag Switzerland
 
277-0123309-3/16/1 20-Nov-2009 66VDR99 3003202351 Viset Niyom Manufacture Thailand
 
277-0122159-3/15/1/C 04-Nov-2009 66VDY99 3007555812 Nguan Heng Chan Tea Thailand
 
T94-0051541-5/3/1/D 17-Nov-2009 66VDY99 3003887382 Biferdil Srl Argentina
 
T94-0051541-5/5/1/B 17-Nov-2009 66VDY99 3003887382 Biferdil Srl Argentina
 
112-6279732-0/1/1 02-Nov-2009 66VIP99 3003609643 Radpharm Scientific Australia
 
112-5279195-2/2/1 05-Nov-2009 66VIP99 3007210501 Sanofi Aventis Colombia
 
112-9106425-4/1/1 06-Nov-2009 66VIP99 3006972430 Hillside Pharmacy Canada
 
112-7002415-4/1/1 06-Nov-2009 66VIS99 3006526270 Nutrasource Diagnostics Inc Canada
 
112-3060312-1/1/1 04-Nov-2009 66VIY99 3005056801 Zandu Pharmaceutical Works India
 
112-4684742-3/1/1 04-Nov-2009 66YCB99 3007147081 Chx Lab Mexico
 
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