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 |
|---|---|---|---|---|
| 112-5874146-4/1/1 | 02-Nov-2009 | 61HCB99 | 3003452425 | Zydus Cadilla |
| 112-5874146-4/3/1 | 02-Nov-2009 | 60DCB04 | 3003452425 | Zydus Cadilla |
| 112-5839951-1/1/1 | 02-Nov-2009 | 54AEY90 | 3005736006 | Ayushakti |
| 112-6113071-3/1/1/A | 02-Nov-2009 | 54ABA99 | 3004432923 | Sharangdhar Pharma Pvt Ltd |
| 112-6113071-3/1/1/B | 02-Nov-2009 | 54ABA99 | 3004432923 | Sharangdhar Pharma Pvt Ltd |
| 112-6113071-3/1/1/C | 02-Nov-2009 | 54ABA99 | 3004432923 | Sharangdhar Pharma Pvt Ltd |
| 112-6113071-3/1/1/D | 02-Nov-2009 | 54ABA99 | 3004432923 | Sharangdhar Pharma Pvt Ltd |
| 112-6113071-3/1/1/E | 02-Nov-2009 | 54ABA99 | 3004432923 | Sharangdhar Pharma Pvt Ltd |
| 112-6113071-3/1/1/F | 02-Nov-2009 | 54ABA99 | 3004432923 | Sharangdhar Pharma Pvt Ltd |
| 112-6113071-3/1/1/G | 02-Nov-2009 | 54ABA99 | 3004432923 | Sharangdhar Pharma Pvt Ltd |
| 112-6113071-3/1/1/H | 02-Nov-2009 | 54ABA99 | 3004432923 | Sharangdhar Pharma Pvt Ltd |
| 112-6113071-3/1/1/I | 02-Nov-2009 | 54ABA99 | 3004432923 | Sharangdhar Pharma Pvt Ltd |
| 112-6113071-3/1/1/J | 02-Nov-2009 | 54ABA99 | 3004432923 | Sharangdhar Pharma Pvt Ltd |
| 112-6113071-3/1/1/K | 02-Nov-2009 | 54ABA99 | 3004432923 | Sharangdhar Pharma Pvt Ltd |
| 112-6113071-3/1/1/L | 02-Nov-2009 | 54ABA99 | 3004432923 | Sharangdhar Pharma Pvt Ltd |
| 112-6113071-3/1/1/M | 02-Nov-2009 | 54ABA99 | 3004432923 | Sharangdhar Pharma Pvt Ltd |
| 112-6113071-3/1/1/N | 02-Nov-2009 | 54ABA99 | 3004432923 | Sharangdhar Pharma Pvt Ltd |
| 112-6113071-3/1/1/O | 02-Nov-2009 | 54ABA99 | 3004432923 | Sharangdhar Pharma Pvt Ltd |
| 112-4892713-2/1/1 | 02-Nov-2009 | 76ELW | 3006388441 | Vengom Impex |
| 300-3294586-5/6/1 | 02-Nov-2009 | 28AGR18 | 3002156998 | Obson International |
| 300-3294586-5/7/1 | 02-Nov-2009 | 28AGR18 | 3002156998 | Obson International |
| 300-3294586-5/8/1 | 02-Nov-2009 | 02GGY08 | 3002156998 | Obson International |
| WUG-0147646-3/2/1 | 02-Nov-2009 | 03YGH99 | 3004163658 | Vivek Agro Products |
| 112-4940497-4/1/1 | 03-Nov-2009 | 53YY99 | 3003813578 | Kaya Kalp Herbals Pvt. Ltd. |
| 112-4940497-4/1/2/A | 03-Nov-2009 | 53YY99 | 3003813578 | Kaya Kalp Herbals Pvt. Ltd. |
| 112-4940497-4/1/2/B | 03-Nov-2009 | 60BAY01 | 3003813578 | Kaya Kalp Herbals Pvt. Ltd. |
| 112-4940497-4/1/2/C | 03-Nov-2009 | 60BAY01 | 3003813578 | Kaya Kalp Herbals Pvt. Ltd. |
| 112-4940497-4/1/2/D | 03-Nov-2009 | 53QC99 | 3003813578 | Kaya Kalp Herbals Pvt. Ltd. |
| 112-9449399-7/1/1 | 03-Nov-2009 | 57HD36 | 3007904099 | Bharat Biotech International Lim |
| AEF-0011563-6/4/1 | 03-Nov-2009 | 36BCT99 | 3004256158 | Haldiram Exports (Pvt) Limited |
| KM6-0112195-7/12/1 | 03-Nov-2009 | 28AGT16 | 3004267298 | Adani Food Products Pvt. Ltd |
| BMY-3013700-6/1/1 | 04-Nov-2009 | 03YGT99 | 3004213287 | G. N. Products |
| BMY-3013700-6/1/2 | 04-Nov-2009 | 03YGT99 | 3004213287 | G. N. Products |
| 112-3060312-1/1/1 | 04-Nov-2009 | 66VIY99 | 3005056801 | Zandu Pharmaceutical Works |
| WUG-0147579-6/1/1 | 04-Nov-2009 | 02DAT07 | 3007758201 | Greenonion Organic Foods Pvt Ltd |
| 147-0104306-0/1/1 | 05-Nov-2009 | 24FCI20 | 3008367445 | Global Green Company Ltd. (Corporate Office) |
| 112-5967674-3/1/1 | 05-Nov-2009 | 60CBR09 | 1000640928 | Cadila Pharmaceuticals |
| 594-0198529-2/1/15 | 05-Nov-2009 | 28YGT99 | 2000044683 | Green Bowl Foods |
| 594-0198529-2/2/3 | 05-Nov-2009 | 25HCI99 | 3005189065 | Fudkor India Pvt. Ltd. |
| 594-0198529-2/2/6 | 05-Nov-2009 | 25HCI99 | 3005189065 | Fudkor India Pvt. Ltd. |
| 594-0198529-2/2/7 | 05-Nov-2009 | 25HCI99 | 3005189065 | Fudkor India Pvt. Ltd. |
| 594-0198529-2/2/11 | 05-Nov-2009 | 25HCI99 | 3005189065 | Fudkor India Pvt. Ltd. |
| 594-0198529-2/2/12 | 05-Nov-2009 | 25HCI99 | 3005189065 | Fudkor India Pvt. Ltd. |
| 185-0054190-1/5/1 | 05-Nov-2009 | 07YGT99 | 2000027071 | KITCHEN XPRESS OVERSEAS LIMITED |
| 185-0054190-1/6/1 | 05-Nov-2009 | 07YGT99 | 2000027071 | KITCHEN XPRESS OVERSEAS LIMITED |
| 185-0054236-2/6/1 | 05-Nov-2009 | 07YGT99 | 2000027071 | KITCHEN XPRESS OVERSEAS LIMITED |
| 185-0054236-2/7/1 | 05-Nov-2009 | 07YGT99 | 2000027071 | KITCHEN XPRESS OVERSEAS LIMITED |
| 185-0054236-2/8/1 | 05-Nov-2009 | 07YGT99 | 2000027071 | KITCHEN XPRESS OVERSEAS LIMITED |
| 185-0054236-2/11/1 | 05-Nov-2009 | 07YGT99 | 2000027071 | KITCHEN XPRESS OVERSEAS LIMITED |
| 185-0054236-2/12/1 | 05-Nov-2009 | 07YGT99 | 2000027071 | KITCHEN XPRESS OVERSEAS LIMITED |
| D99-1007268-2/5/2 | 05-Nov-2009 | 03RGE99 | 3005713983 | Garden Namkeens Pvt.Ltd |
| D99-1007268-2/5/3 | 05-Nov-2009 | 03RGE99 | 3005713983 | Garden Namkeens Pvt.Ltd |
| D99-1007268-2/5/4 | 05-Nov-2009 | 03RGE99 | 3005713983 | Garden Namkeens Pvt.Ltd |
| G81-2004394-4/1/2 | 05-Nov-2009 | 03RGO99 | 3000235961 | Himalya International Ltd |
| 231-9119698-2/2/1 | 05-Nov-2009 | 53EY06 | 1000180512 | The Vegetable Vitamin Foods Co.,Ltd |
| 555-0491994-9/3/1 | 06-Nov-2009 | 28AFT54 | 3006551590 | Vkl Global Spices |
| AEK-9631527-6/1/1 | 06-Nov-2009 | 28BHY54 | 3007801948 | Vallabhadas |
| 112-9040085-5/1/1 | 06-Nov-2009 | 54FGF94 | 3004751279 | Surya Herbal Ltd |
| AEK-9635149-5/1/1 | 06-Nov-2009 | 28BYY54 | 3004298252 | Vallabhdas Kanji Limited |
| 112-9040085-5/1/2 | 06-Nov-2009 | 54YBF01 | 3004751279 | Surya Herbal Ltd |
| 112-9192877-1/1/1 | 06-Nov-2009 | 61ECK11 | 3007355139 | Cipla Ltd |
| 224-3070439-9/5/1 | 06-Nov-2009 | 33EGT99 | 3002156998 | Obson International |
| 224-3070439-9/5/2 | 06-Nov-2009 | 33EGT99 | 3002156998 | Obson International |
| 224-3070439-9/6/1 | 06-Nov-2009 | 28AGH99 | 3002156998 | Obson International |
| 224-3070439-9/10/1 | 06-Nov-2009 | 28FGT03 | 3002156998 | Obson International |
| 224-3070439-9/11/1 | 06-Nov-2009 | 07YGT99 | 3002156998 | Obson International |
| 224-3070439-9/13/1 | 06-Nov-2009 | 07BGT99 | 3002156998 | Obson International |
| 224-3070439-9/14/1 | 06-Nov-2009 | 03HGT99 | 3002156998 | Obson International |
| 224-3070439-9/14/2 | 06-Nov-2009 | 03HGT99 | 3002156998 | Obson International |
| 224-3070439-9/14/3 | 06-Nov-2009 | 03HGT99 | 3002156998 | Obson International |
| 224-3070439-9/14/4 | 06-Nov-2009 | 03HGT99 | 3002156998 | Obson International |
| AEK-9963681-9/1/1 | 09-Nov-2009 | 54YYY99 | 3007899211 | Ds Bhullar |
| N77-0162741-6/1/1 | 09-Nov-2009 | 54FYL99 | 3004682313 | Aventis Pharma LTD |
| N77-0162741-6/8/1 | 09-Nov-2009 | 54FYL99 | 3004259394 | The Himalaya Drug Company |
| AEK-9958098-3/1/1 | 09-Nov-2009 | 66NCA07 | 3007882846 | Krishna Medical |
| UPS-6180085-8/1/1 | 09-Nov-2009 | 66VCC99 | 3007220093 | Munir Khan |
| UPS-6140486-7/1/1 | 09-Nov-2009 | 54FYY99 | 3007220093 | Munir Khan |
| WUG-0146767-8/1/1 | 09-Nov-2009 | 66VBL99 | 2000024695 | Vedic Bio Labs Pvt Ltd |
| WUG-0146767-8/1/2 | 09-Nov-2009 | 66VAL99 | 2000024695 | Vedic Bio Labs Pvt Ltd |
| WUG-0146767-8/3/1 | 09-Nov-2009 | 66VAL99 | 2000024695 | Vedic Bio Labs Pvt Ltd |
| WUG-0147496-3/10/1 | 09-Nov-2009 | 45LC99 | 1000200006 | M/S KESHAV EXPORTS PVT LTD |
| WUG-0147496-3/11/1 | 09-Nov-2009 | 45FH99 | 1000200006 | M/S KESHAV EXPORTS PVT LTD |
| 112-9379938-6/1/1 | 12-Nov-2009 | 62GCA90 | 3007894960 | Ankar Drugs & Pharma Ltd |
| 112-9379938-6/1/2 | 12-Nov-2009 | 60LCE69 | 3007517883 | Zydus Healthcare |
| 112-9379938-6/1/3 | 12-Nov-2009 | 62GDA41 | 3006091104 | Aristo Pharmaceuticals |
| 112-9379938-6/1/4 | 12-Nov-2009 | 66VDA99 | 3007894966 | Merck Ltd |
| 112-9379938-6/1/5 | 12-Nov-2009 | 61TCA27 | 3007894961 | Cipla Ltd |
| 112-9379938-6/1/6 | 12-Nov-2009 | 61XCA45 | 3007894962 | Emcure Pharmaceuticals |
| 112-9379938-6/1/7 | 12-Nov-2009 | 66VDA99 | 3007894968 | Remidx Pharma Pvt Ltd |
| 112-9379938-6/1/8 | 12-Nov-2009 | 66VDA99 | 3007894968 | Remidx Pharma Pvt Ltd |
| 112-9379938-6/1/9 | 12-Nov-2009 | 60LDA69 | 3007894965 | Johnson & Johnson |
| 112-9379938-6/1/10 | 12-Nov-2009 | 61XDK08 | 3007894963 | Himalaya Drugs Company |
| 112-9379938-6/2/1 | 12-Nov-2009 | 64ECF03 | 3007894969 | Solvay Pharma Ltd |
| 112-9379938-6/2/2 | 12-Nov-2009 | 62KCA05 | 3007894965 | Johnson & Johnson |
| 112-9379938-6/3/1 | 12-Nov-2009 | 62TCA07 | 3007894970 | Sun Pharma Sikkim |
| 112-9379938-6/4/1 | 12-Nov-2009 | 65VCA56 | 3007894959 | Acme Formulation Pvt Ltd |
| KM6-0043630-7/12/2 | 12-Nov-2009 | 34FFT07 | 3003416038 | Dhara Foods Pvt. Ltd. |
| KM6-0111924-1/2/11 | 13-Nov-2009 | 07YGT99 | 1000410684 | Shivdeep Industries Limited |
| KM6-0111924-1/2/17 | 13-Nov-2009 | 07YGT99 | 1000410684 | Shivdeep Industries Limited |
| RE9-0007343-8/1/1 | 16-Nov-2009 | 24AGT09 | 3005428233 | Devi Exports Pvt Ltd |
| RE9-0007343-8/2/1 | 16-Nov-2009 | 24AGT09 | 3005428233 | Devi Exports Pvt Ltd |
| RE9-0007343-8/3/1 | 16-Nov-2009 | 24AGT17 | 3005428233 | Devi Exports Pvt Ltd |
| RE9-0007343-8/4/1 | 16-Nov-2009 | 24AGT09 | 3005428233 | Devi Exports Pvt Ltd |
| DP4-0489885-1/3/1 | 16-Nov-2009 | 37KGT23 | 3004258835 | SGR (777) Foods Pvt. Ltd. |
| DP4-0489885-1/3/2 | 16-Nov-2009 | 37KGT23 | 3004258835 | SGR (777) Foods Pvt. Ltd. |
| UPS-5859898-6/1/1 | 17-Nov-2009 | 45CD99 | 3007837896 | Vivital |
| 112-9337572-4/1/1 | 17-Nov-2009 | 66MDA03 | 3005012007 | Aristo Pharmaceuticals Ltd |
| AEK-6602840-4/1/1 | 17-Nov-2009 | 55QP20 | 3007880538 | Wraps Design House |
| AEK-6602840-4/1/2 | 17-Nov-2009 | 62OCK26 | 3007880538 | Wraps Design House |
| FY4-0061352-4/2/1/B | 17-Nov-2009 | 63RAJ06 | 3006568160 | LIGHTWAVE TRADING COMPANY PRIVATE LIMITED |
| 334-2761257-8/1/1 | 17-Nov-2009 | 60CCA09 | 3007309614 | Malladi Drugs & Pharmaceuticals Ltd |
| 334-2761257-8/2/1 | 17-Nov-2009 | 61XAS08 | 3007309614 | Malladi Drugs & Pharmaceuticals Ltd |
| 112-9653768-4/1/1 | 17-Nov-2009 | 62VCA45 | 1000344428 | Natco Pharma Ltd |
| 113-4845922-0/7/1 | 18-Nov-2009 | 21HGT99 | 3007164155 | QUALITY SPICES & FOOD EXPORTS PVT.LTD. |
| 113-4845922-0/12/1 | 18-Nov-2009 | 21HGT99 | 3007164155 | QUALITY SPICES & FOOD EXPORTS PVT.LTD. |
| 113-4843246-6/13/1 | 18-Nov-2009 | 21TGT14 | 3007164155 | QUALITY SPICES & FOOD EXPORTS PVT.LTD. |
| 113-4843246-6/18/1 | 18-Nov-2009 | 21TGT14 | 3007164155 | QUALITY SPICES & FOOD EXPORTS PVT.LTD. |
| 112-8269428-3/1/1 | 18-Nov-2009 | 66VDA99 | 3007687039 | Ajmera Pharmaceuticals |
| 112-8269428-3/1/2 | 18-Nov-2009 | 66VDJ99 | 3007687042 | Surya Ayurveda Nilayam |
| 112-8269428-3/1/3 | 18-Nov-2009 | 66VDE99 | 3007687041 | Herbazalive |
| 112-8269428-3/2/1 | 18-Nov-2009 | 54YCF99 | 3007687041 | Herbazalive |
| T40-0763577-3/1/1 | 19-Nov-2009 | 22HVF99 | 3003360337 | Ra India |
| H77-0118142-9/13/1 | 20-Nov-2009 | 28BGH19 | 3004270701 | RAMDEV FOOD PRODUCTS PVT. LTD. |
| UPS-6371583-1/1/1 | 23-Nov-2009 | 66VCC99 | 3007930676 | Rahim Bhai |
| UPS-6371583-1/1/2 | 23-Nov-2009 | 66VCC99 | 3007930676 | Rahim Bhai |
| 112-9697190-9/1/1 | 23-Nov-2009 | 61XAS37 | 3007939093 | Pharma Rx Chemical Corporation |
| H67-1341443-0/1/1 | 23-Nov-2009 | 24KDE50 | 3004883870 | Mtr International |
| H67-1341443-0/2/1 | 23-Nov-2009 | 24ADE06 | 3004883870 | Mtr International |
| H67-1341443-0/3/1 | 23-Nov-2009 | 25NDE06 | 3004883870 | Mtr International |
| H67-1341443-0/4/1 | 23-Nov-2009 | 24CDE07 | 3004883870 | Mtr International |
| H67-1341443-0/5/1 | 23-Nov-2009 | 38CDE28 | 3004883870 | Mtr International |
| H67-1341443-0/6/1 | 23-Nov-2009 | 38CDE28 | 3004883870 | Mtr International |
| H67-1341443-0/7/1 | 23-Nov-2009 | 38CDE99 | 3004883870 | Mtr International |
| H67-1341443-0/8/1 | 23-Nov-2009 | 38CDE99 | 3004883870 | Mtr International |
| H67-1341443-0/9/1 | 23-Nov-2009 | 38CDE28 | 3004883870 | Mtr International |
| H67-1341443-0/10/1 | 23-Nov-2009 | 25HDE99 | 3004883870 | Mtr International |
| H67-1341443-0/11/1 | 23-Nov-2009 | 25NDE06 | 3004883870 | Mtr International |
| H67-1341443-0/13/1 | 23-Nov-2009 | 25NDE06 | 3004883870 | Mtr International |
| H67-1341443-0/14/1 | 23-Nov-2009 | 24EDE99 | 3004883870 | Mtr International |
| H67-1341443-0/15/1 | 23-Nov-2009 | 25HDE99 | 3004883870 | Mtr International |
| H67-1341443-0/16/1 | 23-Nov-2009 | 25NDE25 | 3004883870 | Mtr International |
| H67-1341443-0/17/1 | 23-Nov-2009 | 24VDE25 | 3004883870 | Mtr International |
| H67-1341443-0/18/1 | 23-Nov-2009 | 25HDE99 | 3004883870 | Mtr International |
| KM6-0043549-9/10/1 | 23-Nov-2009 | 13BGT01 | 3007411605 | Keshav Exports Pvt. Ltd. |
| KM6-0043549-9/10/2 | 23-Nov-2009 | 13BGT01 | 3007411605 | Keshav Exports Pvt. Ltd. |
| AD1-0427446-0/28/1 | 23-Nov-2009 | 36BCT02 | 3004256158 | Haldiram Exports (Pvt) Limited |
| 336-5466946-7/8/1 | 24-Nov-2009 | 21UHT05 | 3007750178 | Tastel |
| 112-9874024-5/1/1 | 24-Nov-2009 | 61XCS99 | 3006898803 | Glenmark Generics |
| 112-9600155-8/1/1 | 25-Nov-2009 | 60CCS09 | 3002829795 | Harika Drugs Private Limited |
| HA9-0900081-2/2/1 | 30-Nov-2009 | 03HGT99 | 3004672062 | M.M. Enterprise |
| HA9-0900081-2/9/2 | 30-Nov-2009 | 26CCT11 | 3007712906 | Bhawani Silicate Industries |
| HA9-0900081-2/10/1/A | 30-Nov-2009 | 26CCT11 | 3007712906 | Bhawani Silicate Industries |
| HA9-0900081-2/11/1 | 30-Nov-2009 | 21CCT99 | 3006706593 | Hershey India |
| HA9-0900082-0/11/1 | 30-Nov-2009 | 21CCT99 | 3007693615 | Rushabh Electricals |
| HA9-0900082-0/12/3 | 30-Nov-2009 | 29WCT02 | 3007693615 | Rushabh Electricals |
| HA9-0900093-7/7/3 | 30-Nov-2009 | 28CGT18 | 3004254426 | Thakar Exports |
| HA9-0900093-7/17/1 | 30-Nov-2009 | 28CCT39 | 3004254426 | Thakar Exports |
| 991-0172113-4/1/1 | 30-Nov-2009 | 16JFT01 | 3004257461 | Nila Seafoods Pvt. Ltd. |
| 185-0054259-4/1/1 | 30-Nov-2009 | 28AGT08 | 2000027071 | KITCHEN XPRESS OVERSEAS LIMITED |
| 185-0054259-4/2/1 | 30-Nov-2009 | 28AGT08 | 2000027071 | KITCHEN XPRESS OVERSEAS LIMITED |
| 185-0054259-4/3/1 | 30-Nov-2009 | 28AGT08 | 2000027071 | KITCHEN XPRESS OVERSEAS LIMITED |
| 185-0054259-4/7/1 | 30-Nov-2009 | 28AGT08 | 2000027071 | KITCHEN XPRESS OVERSEAS LIMITED |
| 185-0054259-4/8/1 | 30-Nov-2009 | 28AGT08 | 2000027071 | KITCHEN XPRESS OVERSEAS LIMITED |
| WUG-0148588-6/8/1 | 30-Nov-2009 | 54FRT99 | 3004328659 | AABHAR INTERNATIONAL |
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