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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 India


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
112-6775561-3/1/1 01-Jun-2010 64UCS06 3002806702 Cipla, Ltd.
 
BSA-0003431-7/1/1 01-Jun-2010 28BGT08 3008872359 Obson International Pvt. Ltd.
 
BSA-0003431-7/2/1 01-Jun-2010 28BGT08 3008872359 Obson International Pvt. Ltd.
 
BSA-0003431-7/3/1 01-Jun-2010 28BGT08 3008872359 Obson International Pvt. Ltd.
 
WUG-0149972-1/12/1 01-Jun-2010 66YDL99 1000200006 M/S KESHAV EXPORTS PVT LTD
 
WUG-0149972-1/15/1 01-Jun-2010 45LC99 1000200006 M/S KESHAV EXPORTS PVT LTD
 
WUG-0149972-1/32/1 01-Jun-2010 54FBL99 1000200006 M/S KESHAV EXPORTS PVT LTD
 
WUG-0149972-1/43/1 01-Jun-2010 54FCR99 1000200006 M/S KESHAV EXPORTS PVT LTD
 
WUG-0149972-1/56/3 01-Jun-2010 54FRT99 1000200006 M/S KESHAV EXPORTS PVT LTD
 
XXX-0173755-1/1/1 02-Jun-2010 54FYY99 3004259394 The Himalaya Drug Company
 
300-3440138-8/57/1 02-Jun-2010 02GGY08 3004482421 Ruchi Soya Industries Ltd
 
112-6769182-6/4/1 02-Jun-2010 64LCJ08 3006585377 Holden Medical Laboratories
 
112-6769182-6/4/2 02-Jun-2010 64LCP41 3006585372 Alkem Laboratories Ltd
 
112-6769182-6/5/1 02-Jun-2010 61RCA11 3008281350 Ambrosia Remedies
 
112-6769182-6/5/2 02-Jun-2010 61WCA04 3006585377 Holden Medical Laboratories
 
112-6769182-6/6/1 02-Jun-2010 56KCO11 3008281351 Galssinc
 
112-6769182-6/8/1 02-Jun-2010 63FCA06 3006585377 Holden Medical Laboratories
 
112-6769182-6/8/2 02-Jun-2010 64BCP24 3002647489 Gland Pharma Limited
 
112-6769182-6/8/3 02-Jun-2010 65NBC55 3001353081 Bdh Industries
 
112-6769182-6/9/1 02-Jun-2010 61FAB33 3006585377 Holden Medical Laboratories
 
112-6769182-6/9/2 02-Jun-2010 61FAB33 3006585377 Holden Medical Laboratories
 
112-6769182-6/11/1 02-Jun-2010 63BAQ01 3008155622 Ciron
 
112-6769182-6/11/2 02-Jun-2010 63BAQ01 3003699941 Cipla Ltd
 
112-6769182-6/13/1 02-Jun-2010 61WAA47 3006585377 Holden Medical Laboratories
 
112-6769182-6/14/1 02-Jun-2010 66SAA27 3008173089 Medopharm
 
112-6769182-6/15/1 02-Jun-2010 62KAA08 3006585377 Holden Medical Laboratories
 
880-0077831-1/13/2 02-Jun-2010 07YGT99 3007217725 Haldiram Manufacturing Co. Pvt. Ltd.
 
880-0077941-8/8/2 02-Jun-2010 12YEE99 3004256158 Haldiram Exports (Pvt) Limited
 
112-6807998-9/1/1 03-Jun-2010 84LLN 3008292130 Diabetik Footcare
 
K80-0979727-6/6/3 03-Jun-2010 28AGT18 3004270701 RAMDEV FOOD PRODUCTS PVT. LTD.
 
K80-0979727-6/15/3 03-Jun-2010 27YCT03 3004675050 ANAND FOOD & DAIRY PRODUCTS
 
300-3440159-4/1/1 04-Jun-2010 07BGY99 3004256158 Haldiram Exports (Pvt) Limited
 
KM6-0046234-5/11/1 04-Jun-2010 28BGT54 3007014502 Harihar Foods Pvt. Ltd
 
KM6-0046234-5/11/2 04-Jun-2010 28BGT54 3007014502 Harihar Foods Pvt. Ltd
 
AN7-0000388-0/1/1 09-Jun-2010 21TEH14 3008185581 Indoworld Trading Corp
 
185-0054879-9/2/1 09-Jun-2010 41EGT99 2000027071 KITCHEN XPRESS OVERSEAS LIMITED
 
KM6-0046307-9/15/1 09-Jun-2010 28BGT08 3008473286 Keval Exports Pvt.Ltd
 
628-0137134-5/1/1 09-Jun-2010 65FBK06 3005048761 Liv Medica Products Pvt. Ltd.
 
AEK-8015257-8/1/1 09-Jun-2010 61XAR39 3003920544 Supriya Lifecience Ltd.
 
WQ8-9612941-5/2/1 09-Jun-2010 61HBS05 3003768909 Kumar Organic Products Ltd.
 
WQ8-9613128-8/2/1/A 09-Jun-2010 62CBS41 3003768909 Kumar Organic Products Ltd.
 
WQ8-9613128-8/2/1/B 09-Jun-2010 64ACY20 3003768909 Kumar Organic Products Ltd.
 
WQ8-9613128-8/2/1/C 09-Jun-2010 64ACY20 3003768909 Kumar Organic Products Ltd.
 
300-3438210-9/9/1 10-Jun-2010 33ECY99 3004256158 Haldiram Exports (Pvt) Limited
 
300-3439409-6/44/1 10-Jun-2010 53FH02 3004307587 Mahashian Di Hatti Ltd.
 
300-3440978-7/1/1 10-Jun-2010 03YGY99 1000185118 Veerprabhu Export House
 
K74-0155146-3/5/1 10-Jun-2010 03YGY99 3007393544 Harika Foods & Innovations Ltd
 
KM6-0114268-0/16/1 11-Jun-2010 55QP16 3008287641 R.k. Pharma
 
KM6-0114268-0/16/2 11-Jun-2010 55QP16 3008287641 R.k. Pharma
 
KM6-0114268-0/17/2 11-Jun-2010 63RAY04 2000007155 HENKEL INDIA LIMITED
 
KM6-0114268-0/10/1 11-Jun-2010 37BGT99 3007329246 dakhane infraproject pvt.ltd.
 
112-7246501-8/1/1 11-Jun-2010 66VIP99 3008341914 Kalbe Farma Pt
 
G05-1129427-7/1/1 11-Jun-2010 02EFT02 3007603541 Annai Enterprises
 
G05-1129427-7/1/2 11-Jun-2010 02EFT02 3007603541 Annai Enterprises
 
G05-1129427-7/1/3 11-Jun-2010 02EFT02 3007603541 Annai Enterprises
 
G05-1129427-7/1/4 11-Jun-2010 02EFT02 3007603541 Annai Enterprises
 
G05-1129427-7/1/5 11-Jun-2010 02EFT02 3007603541 Annai Enterprises
 
G05-1129427-7/1/6 11-Jun-2010 02EFT02 3007603541 Annai Enterprises
 
G05-1129427-7/1/7 11-Jun-2010 02EFT02 3007603541 Annai Enterprises
 
G05-1129427-7/1/8 11-Jun-2010 02EFT02 3007603541 Annai Enterprises
 
UPS-8355340-2/1/1 14-Jun-2010 56ICK76 3008344644 Devang Bhai
 
H67-1350504-7/27/1 16-Jun-2010 24FGT02 3004287737 ADF Foods Limited
 
660-2505298-7/8/1 16-Jun-2010 24HGT08 2000027071 KITCHEN XPRESS OVERSEAS LIMITED
 
660-2505298-7/8/2 16-Jun-2010 24HGT08 2000027071 KITCHEN XPRESS OVERSEAS LIMITED
 
660-2505298-7/8/3 16-Jun-2010 24HGT08 2000027071 KITCHEN XPRESS OVERSEAS LIMITED
 
880-0078251-1/16/2 18-Jun-2010 07YYY99 3004256158 Haldiram Exports (Pvt) Limited
 
222-3044386-7/1/1 19-Jun-2010 41EYT99 3008354543 Isha Business Private Ltd
 
AEK-8016168-6/1/1 21-Jun-2010 56ICA76 3008323555 Apollo Hospitals Enterprise Ltd
 
AEK-8016168-6/2/1 21-Jun-2010 62LCA99 3008323555 Apollo Hospitals Enterprise Ltd
 
AEK-8016168-6/2/2 21-Jun-2010 61WCA45 3008323555 Apollo Hospitals Enterprise Ltd
 
WUG-0150920-6/1/1 21-Jun-2010 28BGH16 3004257425 J.B.SPICES
 
WUG-0150920-6/1/2 21-Jun-2010 28BGH16 3004257425 J.B.SPICES
 
WUG-0150920-6/3/1 21-Jun-2010 28BGH15 3004257425 J.B.SPICES
 
WUG-0150920-6/3/2 21-Jun-2010 28BGH15 3004257425 J.B.SPICES
 
EBX-0801312-4/1/1 21-Jun-2010 29BCT02 3004328659 AABHAR INTERNATIONAL
 
EBX-0801312-4/1/2 21-Jun-2010 29BCT50 3004328659 AABHAR INTERNATIONAL
 
EBX-0801312-4/1/3 21-Jun-2010 29BCT02 3004328659 AABHAR INTERNATIONAL
 
EBX-0801312-4/4/1 21-Jun-2010 50BGY60 3004328659 AABHAR INTERNATIONAL
 
EBX-0801312-4/5/1 21-Jun-2010 28BGH99 3004328659 AABHAR INTERNATIONAL
 
EBX-0801312-4/5/2 21-Jun-2010 28BGH99 3004328659 AABHAR INTERNATIONAL
 
BSA-0003803-7/15/1 22-Jun-2010 23KYT02 3008301002 Veerprabhu Export House
 
ERH-0002626-8/1/1 22-Jun-2010 28BFH08 3004975929 INDIAN PRODUCTS LIMITED 100% EOU
 
ERH-0002626-8/2/1 22-Jun-2010 28BFH08 3004975929 INDIAN PRODUCTS LIMITED 100% EOU
 
XXX-0285566-7/1/3 22-Jun-2010 62YDY07 3005700533 Caplin Laboratories Limited
 
XXX-0173669-4/1/1 22-Jun-2010 66VIY99 3008308886 Ranbaxy Laboratories
 
WUG-0150786-1/4/1 22-Jun-2010 28AGH08 3005248947 SHREE BHAGWATI FLOUR & FOODS PVT. LTD
 
WUG-0150786-1/4/2 22-Jun-2010 28AGH08 3005248947 SHREE BHAGWATI FLOUR & FOODS PVT. LTD
 
554-5285125-0/1/1 22-Jun-2010 60TCS99 3007785633 Hetero Labs Ltd
 
300-3439808-9/14/1 23-Jun-2010 03HGY99 1000200006 M/S KESHAV EXPORTS PVT LTD
 
300-3440640-3/4/1 23-Jun-2010 50NGY18 3002320425 Aarav international
 
UPS-3105336-0/1/1 23-Jun-2010 02DGT07 2000014997 Sarvpriya Exports Private Ltd.
 
AYG-1002130-6/5/1 24-Jun-2010 28AGT18 3004254426 Thakar Exports
 
AYG-1002130-6/6/1 24-Jun-2010 28AGT18 3004254426 Thakar Exports
 
AEK-8017045-5/1/1 24-Jun-2010 61JDA08 3008340040 Saurab Roy
 
DO7-8227711-8/1/1 24-Jun-2010 54FCA94 3008065951 Avn Ayurveda Formulations Private Limited
 
DO7-8227525-2/1/1 24-Jun-2010 61EDY99 3008334405 Ram Joshi
 
BPC-0201925-5/8/1 24-Jun-2010 28BHT54 3007349837 Baba Global Limited
 
W04-0060358-9/6/1 25-Jun-2010 36BCE09 3004256158 Haldiram Exports (Pvt) Limited
 
RE9-0007687-8/3/1 25-Jun-2010 36BGT06 3005428233 Devi Exports Pvt Ltd
 
WUG-0150223-5/42/1 26-Jun-2010 53LC99 3004468758 Supreme Mehandi
 
XXX-0173817-9/1/1 28-Jun-2010 64LDL06 3003705104 Shalina Laboratories Limited
 
112-7179929-2/2/1 29-Jun-2010 62YDA07 3006948036 Caplin Point Lab Ltd
 
KM6-0047193-2/14/1 30-Jun-2010 28BGT08 3004250861 ADARSH GLOBAL LIMITED
 
KM6-0047193-2/14/2 30-Jun-2010 28BGT08 3004250861 ADARSH GLOBAL LIMITED
 
KM6-0047164-3/18/1 30-Jun-2010 52AMD54 3008319195 Kapasi Handicrafts Emporium
 
KM6-0047352-4/2/1 30-Jun-2010 30YCT99 3001061253 Cadbury India Limited
 
KM6-0047352-4/2/2 30-Jun-2010 30YCT99 3001061253 Cadbury India Limited
 
002-1176638-1/1/1 30-Jun-2010 61WAJ31 1000257863 Aarti Drugs Ltd
 
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