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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 Romania

Entry/doc/line/sfx Refusal Date Product
AEK-8375226-7/1/2 16-May-2011 62OCA27 3008907296 Dragomir Emilian
AEK-8375226-7/1/1 16-May-2011 62OCA05 3008907296 Dragomir Emilian
AEK-8375226-7/2/1 16-May-2011 64BCA24 3008907296 Dragomir Emilian
AEK-8375226-7/2/2 16-May-2011 64BCA37 3008907296 Dragomir Emilian
AEK-8375226-7/1/3 16-May-2011 61JCA16 3008907296 Dragomir Emilian
073-0093292-3/2/1 16-May-2011 12CEO16 3004409937 S.C. Lacto Baneasa S.R.L.
073-0093292-3/3/1 16-May-2011 12CVO16 3004409937 S.C. Lacto Baneasa S.R.L.
XXX-0175213-9/2/4 17-May-2011 62ODA44 3007339139 Ranbaxy
XXX-0175213-9/2/3 17-May-2011 56KDA99 3006253465 Zentiva S.A.
XXX-0175213-9/2/1 17-May-2011 62OCA29 3007564647 Labormed Pharma Sa
XXX-0175213-9/2/2 17-May-2011 56BCE05 3003489017 Antibiotice S.A.