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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 65-Human and Animal Drugs


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
551-0136361-8/1/1 12-Mar-2012 65CCA09 3009283667 Cmic Cmo Co Ltd Japan
 
AEK-0091589-8/1/1 19-Mar-2012 65JAS31 3001599766 Changzhou Jiaerke Pharmaceuticals Group Corp., Ltd. China
 
XXX-0249024-2/1/1 05-Mar-2012 65JCY21 1000654629 Pfizer Manufacturing Belgium NV Belgium
 
112-5857106-1/1/1 05-Mar-2012 65JDA27 3002307574 Janssen-Ortho Canada
 
BBH-3012890-0/1/8 05-Mar-2012 65LAJ11 3008846426 Bie-Dro Pharm Handelsgesellschaft C Nuyken Kg Germany
 
BBH-3012890-0/3/3 05-Mar-2012 65LAJ11 3008846426 Bie-Dro Pharm Handelsgesellschaft C Nuyken Kg Germany
 
597-0166941-4/1/6/D 29-Mar-2012 65LB11 3008808022 The Face Shop Co Ltd Korea, Republic Of (South)
 
597-0166941-4/1/8/B 29-Mar-2012 65LB11 3008808022 The Face Shop Co Ltd Korea, Republic Of (South)
 
597-0166941-4/1/8/C 29-Mar-2012 65LB11 3008808022 The Face Shop Co Ltd Korea, Republic Of (South)
 
597-0166941-4/32/3/D 29-Mar-2012 65LB11 3008808022 The Face Shop Co Ltd Korea, Republic Of (South)
 
597-0166941-4/32/3/E 29-Mar-2012 65LB11 3008808022 The Face Shop Co Ltd Korea, Republic Of (South)
 
597-0166941-4/32/3/F 29-Mar-2012 65LB11 3008808022 The Face Shop Co Ltd Korea, Republic Of (South)
 
597-0166941-4/32/3/B 29-Mar-2012 65LJ11 3008808022 The Face Shop Co Ltd Korea, Republic Of (South)
 
597-0166941-4/32/3/C 29-Mar-2012 65LJ11 3008808022 The Face Shop Co Ltd Korea, Republic Of (South)
 
112-6095832-2/1/1 06-Mar-2012 65QCA24 3006091104 Aristo Pharmaceuticals India
 
112-6415795-4/2/1 30-Mar-2012 65QCB60 3004771274 Roemmers S.A. Uruguay
 
112-4905327-8/2/1 02-Mar-2012 65QIK02 3008881736 Daejin Chemical Co Ltd Korea, Republic Of (South)
 
KM6-0055843-1/12/1 07-Mar-2012 65RBZ18 3008503996 AASHIYANA FOODSTUFFS India
 
238-0748696-6/1/1 27-Mar-2012 65ZAY01 3005367631 Novartis Healthcare As Denmark
 
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