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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 Indonesia


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
417-0285367-6/2/5 04-Jan-2013 16XGN21 3006292147 UNIT DUA, BUMI MENARA INTERNUSA, PT.
 
417-0285367-6/2/6 04-Jan-2013 16XGN21 3006292147 UNIT DUA, BUMI MENARA INTERNUSA, PT.
 
417-0285367-6/2/8 04-Jan-2013 16XGN21 3006292147 UNIT DUA, BUMI MENARA INTERNUSA, PT.
 
417-0285367-6/2/1 04-Jan-2013 16XGN21 3006292147 UNIT DUA, BUMI MENARA INTERNUSA, PT.
 
417-0285367-6/2/3 04-Jan-2013 16XGN21 3006292147 UNIT DUA, BUMI MENARA INTERNUSA, PT.
 
417-0285367-6/2/4 04-Jan-2013 16XGN21 3006292147 UNIT DUA, BUMI MENARA INTERNUSA, PT.
 
417-0285367-6/2/7 04-Jan-2013 16XGN21 3006292147 UNIT DUA, BUMI MENARA INTERNUSA, PT.
 
417-0285367-6/2/9 04-Jan-2013 16XGN21 3006292147 UNIT DUA, BUMI MENARA INTERNUSA, PT.
 
417-0285367-6/2/10 04-Jan-2013 16XGN21 3006292147 UNIT DUA, BUMI MENARA INTERNUSA, PT.
 
417-0285367-6/2/11 04-Jan-2013 16XGN21 3006292147 UNIT DUA, BUMI MENARA INTERNUSA, PT.
 
417-0285367-6/2/2 04-Jan-2013 16XGN21 3006292147 UNIT DUA, BUMI MENARA INTERNUSA, PT.
 
HK1-0204615-6/1/3 07-Jan-2013 16AGT45 3007584623 PT Awindo International
 
HK1-0204615-6/1/1 07-Jan-2013 16AGT45 3007584623 PT Awindo International
 
HK1-0204615-6/1/2 07-Jan-2013 16AGT45 3007584623 PT Awindo International
 
HK1-0204615-6/1/4 07-Jan-2013 16AGT45 3007584623 PT Awindo International
 
HK1-0204615-6/1/5 07-Jan-2013 16AGT45 3007584623 PT Awindo International
 
HK1-0204615-6/1/6 07-Jan-2013 16AGT45 3007584623 PT Awindo International
 
316-1918454-7/1/1 11-Jan-2013 16AVT37 3005391503 PT. MULTI SARI MAKASSAR
 
E4J-0009340-7/2/1 11-Jan-2013 16SVD37 3007946119 Pt Chen Woo Fishery
 
AEK-0546007-2/1/1 18-Jan-2013 54FIZ99 3009764484 Reza Prasetyo W
 
AEK-0579148-4/1/1 22-Jan-2013 54EYY99 3009643007 Mitra Alam Sejahtera
 
AEK-0645637-6/1/1 22-Jan-2013 98B06 3009599819 Pt Tresindo Asia Prima
 
AEK-0579139-3/1/1 22-Jan-2013 54EYY99 3009558925 Broerry Soetarno
 
AEK-0579141-9/1/1 22-Jan-2013 54EYY99 3009558925 Broerry Soetarno
 
H67-1402795-9/1/1 23-Jan-2013 16AVT45 3007584623 PT Awindo International
 
H67-1402795-9/2/1 23-Jan-2013 16AVT45 3007584623 PT Awindo International
 
H67-1402795-9/3/1 23-Jan-2013 16AVT45 3007584623 PT Awindo International
 
H67-1402795-9/4/1 23-Jan-2013 16AVT45 3007584623 PT Awindo International
 
H67-1402795-9/5/1 23-Jan-2013 16AVT45 3007584623 PT Awindo International
 
H67-1402795-9/6/1 23-Jan-2013 16AVT45 3007584623 PT Awindo International
 
H67-1402795-9/7/1 23-Jan-2013 16AVT45 3007584623 PT Awindo International
 
H67-1402795-9/8/1 23-Jan-2013 16AVT45 3007584623 PT Awindo International
 
H67-1402795-9/9/1 23-Jan-2013 16AVT45 3007584623 PT Awindo International
 
H67-1402795-9/11/1 23-Jan-2013 16AVT45 3007584623 PT Awindo International
 
406-0481566-8/1/1 29-Jan-2013 16AGD53 3004286185 PT.Sabindo Raya Gemilang
 
406-0481566-8/1/2 29-Jan-2013 16AGD53 3004286185 PT.Sabindo Raya Gemilang
 
112-4478182-4/1/1 29-Jan-2013 66BAY99 3008740316 Rama Yogaswara
 
112-4110784-1/1/1 29-Jan-2013 66BAY99 3008740316 Rama Yogaswara
 
594-0230536-7/1/1 31-Jan-2013 16AGT45 3004249162 Pt. Varia Niaga Nusantara
 
112-0090828-9/1/1 31-Jan-2013 66VBU99 3005157144 PT Galenium Pharmasia Laboratories
 
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