Import Refusal Report
-
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 | 3002156998 | Obson International |
| BSA-0003431-7/2/1 | 01-Jun-2010 | 28BGT08 | 3002156998 | Obson International |
| BSA-0003431-7/3/1 | 01-Jun-2010 | 28BGT08 | 3002156998 | Obson International |
| 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 | 3008093078 | Keval Exports Private Limited |
| 628-0137134-5/1/1 | 09-Jun-2010 | 65FBK06 | 3005048761 | Liv Medica Products Pvt. Ltd. |
| AEK-8015257-8/1/1 | 09-Jun-2010 | 61XAR39 | 3007331516 | Supriya Lifescience 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-0173669-4/1/1 | 22-Jun-2010 | 66VIY99 | 3008308886 | Ranbaxy |
| 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 |
-







