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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 56-Antibiotics (Human/Animal)


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
M21-0744915-1/1/1 04-Dec-2011 56BAA05 3006094247 Research Pharmaceutical Co Ltd China
 
XXX-0176509-9/1/2 14-Dec-2011 56BCP52 1259 Hindustan Antibiotics Ltd. India
 
XXX-0176509-9/1/1 14-Dec-2011 56BCP52 3003238213 Alembic Limited India
 
XXX-0176511-5/1/1 14-Dec-2011 56BCP52 3001056209 unknown India
 
112-2082549-6/1/1 12-Dec-2011 56BDA03 3004729711 Glaxo Smith Kline Brazil
 
112-5596693-3/1/1 13-Dec-2011 56BDK03 3008102775 Jageswari Medicine Store India
 
112-6323537-9/1/1/A 27-Dec-2011 56BDK07 3004217089 Medreich Sterilab Limited India
 
M21-0744947-4/3/1 04-Dec-2011 56CCA11 3008367099 Shanghai Trifecta Pharma Ltd. China
 
112-2082549-6/1/2 12-Dec-2011 56CDA71 3004729711 Glaxo Smith Kline Brazil
 
112-2801996-9/1/1 07-Dec-2011 56CDZ68 3002806297 ACS Dobfar s.p.a. (Plant #2) Italy
 
112-8951100-2/1/1 28-Dec-2011 56DAJ49 3006222846 Boehringer Ingelheim It Spa Italy
 
MA7-0689624-2/1/13 23-Dec-2011 56DAY20 3004567236 Carnival Cruise Lines Bahamas
 
112-9657352-4/1/1 28-Dec-2011 56DJK06 3008609721 Mcdonalds Perscriptions #4 Canada
 
112-8426442-4/1/1 13-Dec-2011 56EBO65 3006736885 Glaxosmithkline United Kingdom
 
112-1107328-8/1/1 12-Dec-2011 56ECA20 3008794714 Laboratory Elerte France
 
112-9839425-9/1/1 28-Dec-2011 56ECA20 3006218434 Tolmar, Inc. United States
 
112-9839425-9/1/2 28-Dec-2011 56ECA20 3006218434 Tolmar, Inc. United States
 
XXX-0176508-1/1/4 14-Dec-2011 56ECE80 3001056209 unknown India
 
112-8428927-2/1/2 13-Dec-2011 56FAO13 1317759 Ultra-Seal Corporation United States
 
112-7479684-0/1/7 30-Dec-2011 56FCB14 3008365809 Jsc Biopharm Georgia
 
112-7479684-0/1/5 30-Dec-2011 56FCB14 3004487225 Berlin-Chemie Ag Germany
 
112-7479684-0/1/1 30-Dec-2011 56FCK14 3008365808 G Eliava Institute Of Bacteriophage, Microbiology And Virolo Georgia
 
112-7479684-0/1/4 30-Dec-2011 56FCK14 3008365808 G Eliava Institute Of Bacteriophage, Microbiology And Virolo Georgia
 
112-7479684-0/1/3 30-Dec-2011 56FCK14 3008365808 G Eliava Institute Of Bacteriophage, Microbiology And Virolo Georgia
 
112-7479684-0/1/2 30-Dec-2011 56FCK14 3008365808 G Eliava Institute Of Bacteriophage, Microbiology And Virolo Georgia
 
112-7479684-0/1/6 30-Dec-2011 56FCK14 1000616804 Merckle GmbH Germany
 
906-2117305-4/1/1 16-Dec-2011 56GAS99 3004257189 G. Amphray Laboratories India
 
M41-0783068-7/10/1/A 21-Dec-2011 56GYL99 3006672051 Sabesa El Salvador
 
M41-0783068-7/10/1/D 21-Dec-2011 56GYL99 3009164016 AINSA El Salvador
 
MA7-0689624-2/1/10 23-Dec-2011 56IAY76 3004567236 Carnival Cruise Lines Bahamas
 
M21-0745031-6/5/1 04-Dec-2011 56ICB76 3005144955 Chemo S.A. Lugano Branch Switzerland
 
112-0980417-3/1/1 15-Dec-2011 56OCA02 3002808086 Bayer Pharma AG Germany
 
112-0645670-4/13/1 13-Dec-2011 56YCB99 3006202362 Pfizer De Venezuela Venezuela
 
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