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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 85-Obstetrical & Gynecological


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
315-7352076-9/1/1 28-Jul-2011 85HIS 3003117682 Innolatex Sdn. Bhd. Malaysia
 
315-7352076-9/2/1 28-Jul-2011 85HIS 3003117682 Innolatex Sdn. Bhd. Malaysia
 
315-7352076-9/4/1 28-Jul-2011 85HIS 3003117682 Innolatex Sdn. Bhd. Malaysia
 
315-7352076-9/5/1 28-Jul-2011 85HIS 3003117682 Innolatex Sdn. Bhd. Malaysia
 
315-7352076-9/3/1 28-Jul-2011 85HIS 3003117682 Innolatex Sdn. Bhd. Malaysia
 
315-7352037-1/1/1 28-Jul-2011 85HIS 3003117682 Innolatex Sdn. Bhd. Malaysia
 
315-7352037-1/2/1 28-Jul-2011 85HIS 3003117682 Innolatex Sdn. Bhd. Malaysia
 
315-7352265-8/2/1 28-Jul-2011 85HIS 3003117682 Innolatex Sdn. Bhd. Malaysia
 
315-7352265-8/3/1 28-Jul-2011 85HIS 3003117682 Innolatex Sdn. Bhd. Malaysia
 
315-7352265-8/1/1 28-Jul-2011 85HIS 3003117682 Innolatex Sdn. Bhd. Malaysia
 
853-0525506-0/2/1 05-Jul-2011 85MQE 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0525589-6/4/1 05-Jul-2011 85MQE 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0525481-6/5/1 07-Jul-2011 85MQE 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
853-0525553-2/12/1 07-Jul-2011 85MQE 3002963732 Smiths Healthcare Manufacturing S.a. De C.v. Mexico
 
112-6315922-4/1/1 27-Jul-2011 85MQK 3007588003 Future Mother Co Ltd Japan
 
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