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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
KT5-0278876-5/1/1 03-Jun-2013 79EMF 3009082984 Aadpri Ophthalmic Company
 
KT5-0278876-5/2/1 03-Jun-2013 86KYD 3009082984 Aadpri Ophthalmic Company
 
KT5-0278876-5/3/1 03-Jun-2013 86NYK 3009082984 Aadpri Ophthalmic Company
 
D52-8914700-6/6/2/A 03-Jun-2013 28BGT49 3004290986 Nilamel Exports
 
D52-8914700-6/6/2/B 03-Jun-2013 28BGT49 3004290986 Nilamel Exports
 
112-2634478-2/3/1/B 03-Jun-2013 66VDJ99 3009469208 Unilever India Exports Limited
 
BQE-0005654-5/1/1 03-Jun-2013 28BFH08 3004259362 A B Mauri India Private Limited
 
MK8-0687371-9/9/1 04-Jun-2013 53CK02 3008068405 Blue Heaven Cosmetics Pvt Ltd
 
D52-8914625-5/2/1 04-Jun-2013 28BGT54 3004270701 RAMDEV FOOD PRODUCTS PVT. LTD.
 
F23-9085416-4/8/1 04-Jun-2013 28AGT54 3010048047 Aerath Business Corp
 
112-2724370-2/1/1 04-Jun-2013 76EGG 3010161392 R&D Tech Private Limited
 
112-2726347-8/1/1 04-Jun-2013 86HNR 3006244635 Tulip Surgicals
 
KM6-0127032-5/1/1 04-Jun-2013 02DGT07 3008077089 Amir Chand Jagdish Kumar (Exports) Ltd.
 
KM6-0127032-5/1/2 04-Jun-2013 02DGT07 3008077089 Amir Chand Jagdish Kumar (Exports) Ltd.
 
T77-1174976-4/7/1 04-Jun-2013 21SGD05 3004383398 PARAYIL EXPORTS
 
113-6129883-6/29/1 05-Jun-2013 02DGT07 2000024778 Bush Foods Overseas Pvt. Ltd.
 
113-6129883-6/33/1 05-Jun-2013 02DGT07 2000024778 Bush Foods Overseas Pvt. Ltd.
 
113-6129883-6/34/1 05-Jun-2013 02DGT07 2000024778 Bush Foods Overseas Pvt. Ltd.
 
113-6129883-6/36/1 05-Jun-2013 02DGT07 2000024778 Bush Foods Overseas Pvt. Ltd.
 
113-6130020-2/8/1 05-Jun-2013 02DGT07 2000024778 Bush Foods Overseas Pvt. Ltd.
 
WBO-0029377-3/2/1 05-Jun-2013 50LHH36 2000027876 Stiriti Ayur Therapies Private Limited
 
112-2878235-1/1/1 05-Jun-2013 83NJO 3010186740 Ocimum Biosolutions India Ltd
 
EJE-5217286-1/2/1 05-Jun-2013 78KOG 3010179499 Mitra Medical Services Llp
 
112-2792991-2/1/1 05-Jun-2013 79GAC 3010103855 Ayuron Implants Pvt Ltd
 
112-2792991-2/1/2 05-Jun-2013 87NQO 3010103855 Ayuron Implants Pvt Ltd
 
KM6-0126827-9/10/1 05-Jun-2013 28BGT08 3008792450 Kohlico Foods & Beverages Pvt Ltd
 
KM6-0126827-9/10/2 05-Jun-2013 28BGT08 3008792450 Kohlico Foods & Beverages Pvt Ltd
 
KM6-0126827-9/10/3 05-Jun-2013 28BGT08 3008792450 Kohlico Foods & Beverages Pvt Ltd
 
KM6-0126827-9/10/4 05-Jun-2013 28BGT08 3008792450 Kohlico Foods & Beverages Pvt Ltd
 
KM6-0126827-9/10/5 05-Jun-2013 28BGT08 3008792450 Kohlico Foods & Beverages Pvt Ltd
 
EKU-0006613-1/1/1/C 06-Jun-2013 03AGD99 3008223637 General Mills India Pvt Ltd
 
D52-8914607-3/1/10 06-Jun-2013 37JEE99 3010148023 Anna Group of Companies
 
ES6-4015819-3/1/3 06-Jun-2013 07BGN99 3005098684 AAKASH GLOBAL FOODS PVT.LTD.
 
EJ2-0111860-4/3/2 06-Jun-2013 29BCT50 3003753030 Hindustan Coca Cola Beverages PVT LTD
 
EJ2-0111860-4/3/3 06-Jun-2013 29BCT50 3003753030 Hindustan Coca Cola Beverages PVT LTD
 
EJ2-0111860-4/3/4 06-Jun-2013 29BCT50 3003753030 Hindustan Coca Cola Beverages PVT LTD
 
EJ2-0111860-4/3/6 06-Jun-2013 29BCT50 3003753030 Hindustan Coca Cola Beverages PVT LTD
 
EJ2-0111860-4/3/7 06-Jun-2013 29BCT50 3003753030 Hindustan Coca Cola Beverages PVT LTD
 
EJ2-0111860-4/3/8 06-Jun-2013 29BCT50 3003753030 Hindustan Coca Cola Beverages PVT LTD
 
EJ2-0111860-4/5/1 06-Jun-2013 09AHT02 3005947115 Kaira District Co.Op Milk Producers Unon
 
EJ2-0111860-4/5/2 06-Jun-2013 09AHT02 3005947115 Kaira District Co.Op Milk Producers Unon
 
U16-4663976-9/49/1 07-Jun-2013 28BET99 3008264295 M/S Jhaveri Industries
 
U16-4663976-9/50/1 07-Jun-2013 28BET99 3008264295 M/S Jhaveri Industries
 
EGA-0007526-6/1/1 07-Jun-2013 28AGH12 3003861195 K.B. Enterprises
 
EJ4-0008039-9/6/1 07-Jun-2013 04CGT99 3009598223 Gate Foods Private Limited
 
EJ4-0008039-9/8/1 07-Jun-2013 04CGT99 3009598223 Gate Foods Private Limited
 
KM6-0061159-4/1/1 07-Jun-2013 02DAT07 2000024778 Bush Foods Overseas Pvt. Ltd.
 
185-0057222-9/12/1 07-Jun-2013 25LDE28 3009938308 Manjilas Food Tech Pvt. Ltd.
 
185-0057222-9/23/1 07-Jun-2013 28BGT08 3009205827 Q One Foods & Ingredients Pvt Ltd
 
185-0057222-9/31/1 07-Jun-2013 21TCT14 3008836877 M.O. John & Sons Exports
 
U16-5327690-1/1/1 10-Jun-2013 02DAT02 3004328659 AABHAR INTERNATIONAL
 
9BM-0012997-6/4/1 10-Jun-2013 21XGH05 3008613612 Ganpati Exports
 
BUP-1557616-1/1/1 10-Jun-2013 65JRY24 3006205537 Family Care
 
082-0333974-5/1/1 10-Jun-2013 16XGT21 3001316993 Sandhya Marines Ltd.
 
082-0333974-5/1/2 10-Jun-2013 16XGT21 3001316993 Sandhya Marines Ltd.
 
F95-0037933-9/7/1 11-Jun-2013 76EFW 3010156062 Mannat Motors (India)
 
AYG-1002846-7/1/1 11-Jun-2013 26CHT11 3000313664 Recon Exim India Private Limit
 
AYG-1002846-7/2/1 11-Jun-2013 26CHT11 3000313664 Recon Exim India Private Limit
 
AYG-1002846-7/3/1 11-Jun-2013 26CHT11 3000313664 Recon Exim India Private Limit
 
AYG-1002846-7/4/1 11-Jun-2013 26CHT11 3000313664 Recon Exim India Private Limit
 
AYG-1002846-7/5/1 11-Jun-2013 26CHT11 3000313664 Recon Exim India Private Limit
 
KM6-0126453-4/20/1 11-Jun-2013 66VBY99 3006115568 Shah Maganlal Chunilal Gandhi
 
112-2862214-4/1/1 11-Jun-2013 64TDT08 3008939829 Concord Biotech Li
 
101-3383866-4/92/1 12-Jun-2013 54FEJ99 3005162154 Rangoon Chemical Works, PVT. LTD.
 
KM6-0062225-2/2/2 12-Jun-2013 16JGD05 3010113175 Liberty Frozen Foods Private Limited
 
U16-5327454-2/8/1 12-Jun-2013 28AGT15 3007164155 QUALITY SPICES & FOOD EXPORTS PVT.LTD.
 
U16-5327454-2/36/1 12-Jun-2013 28AGT15 3007164155 QUALITY SPICES & FOOD EXPORTS PVT.LTD.
 
H77-0134814-3/3/1 12-Jun-2013 09AEN02 3003166393 PANCHMAHAL DIST. CO-OPERATIVE MILK PRODUCER UNION LTD.
 
E94-1141399-6/1/1 12-Jun-2013 28BGH61 3004259362 A B Mauri India Private Limited
 
E94-1141399-6/2/1 12-Jun-2013 28BGH61 3004259362 A B Mauri India Private Limited
 
429-0853194-2/14/1 12-Jun-2013 41GET02 2000028959 OMSHAKTHI IMPEX PVT. LTD.
 
429-0853194-2/27/1 12-Jun-2013 02DGT02 2000028959 OMSHAKTHI IMPEX PVT. LTD.
 
G33-0167311-4/3/1 12-Jun-2013 27YFT03 3004283665 DEEPKIRAN FOODS PVT.LTD.
 
U16-4664504-8/11/1 13-Jun-2013 02DGT02 3007164155 QUALITY SPICES & FOOD EXPORTS PVT.LTD.
 
U16-4664504-8/67/1 13-Jun-2013 02DGT02 3007164155 QUALITY SPICES & FOOD EXPORTS PVT.LTD.
 
KM6-0061881-3/1/1 13-Jun-2013 02DGT07 2000024778 Bush Foods Overseas Pvt. Ltd.
 
9WH-1000490-1/4/1 13-Jun-2013 66YDY99 3009549077 Lightwave Trading Co Pvt. Ltd.
 
9WH-1000490-1/15/1 13-Jun-2013 66YCY99 3009549077 Lightwave Trading Co Pvt. Ltd.
 
9WH-1000490-1/16/1 13-Jun-2013 66YCY99 3009549077 Lightwave Trading Co Pvt. Ltd.
 
KM6-0062034-8/6/1 13-Jun-2013 18YGT99 3008783109 Ruchi Soya Industries Ltd (G F Unit)
 
KM6-0062034-8/6/3 13-Jun-2013 18YGT99 3008783109 Ruchi Soya Industries Ltd (G F Unit)
 
KM6-0062034-8/6/2 13-Jun-2013 18YGT99 3008783109 Ruchi Soya Industries Ltd (G F Unit)
 
KM6-0062034-8/34/2 13-Jun-2013 53LH03 3003582492 Hesh Pharma Mfg & Exporter Of Herbal Products
 
791-0023501-4/1/1 14-Jun-2013 85HCY 3005141524 Lifeline Systems Pvt. Ltd.
 
663-2212743-3/1/1 14-Jun-2013 66YCT99 3002949085 Dr. Reddy's Laboratories Limited CTO VI
 
U16-3917138-2/2/1 14-Jun-2013 28BFT15 3007164155 QUALITY SPICES & FOOD EXPORTS PVT.LTD.
 
U16-3917138-2/11/1 14-Jun-2013 28BFT15 3007164155 QUALITY SPICES & FOOD EXPORTS PVT.LTD.
 
U16-3917138-2/45/1 14-Jun-2013 28AGT15 3007164155 QUALITY SPICES & FOOD EXPORTS PVT.LTD.
 
KM6-0126907-9/8/1 14-Jun-2013 53JY01 3009501524 Kohlico Foods & Beverages Pvt Ltd
 
KM6-0126907-9/8/2 14-Jun-2013 53JY01 3009501524 Kohlico Foods & Beverages Pvt Ltd
 
BGK-0025727-0/6/1 17-Jun-2013 21TCT99 3008873571 Kiz Foods
 
D82-2131871-9/1/6 17-Jun-2013 27YCE03 3010189885 Morarka Organic Foods Limited
 
D82-2131871-9/14/1 17-Jun-2013 02GFY99 3010189885 Morarka Organic Foods Limited
 
D82-2131871-9/1/8 17-Jun-2013 27YCE03 3010189885 Morarka Organic Foods Limited
 
594-0231727-1/1/1 17-Jun-2013 02DGH07 2000024778 Bush Foods Overseas Pvt. Ltd.
 
594-0231727-1/1/2 17-Jun-2013 02DGH07 2000024778 Bush Foods Overseas Pvt. Ltd.
 
594-0231727-1/1/3 17-Jun-2013 02DGH07 2000024778 Bush Foods Overseas Pvt. Ltd.
 
KM6-0127077-0/1/1 18-Jun-2013 02DGT07 3008077089 Amir Chand Jagdish Kumar (Exports) Ltd.
 
KM6-0127077-0/1/2 18-Jun-2013 02DGT07 3008077089 Amir Chand Jagdish Kumar (Exports) Ltd.
 
112-2667734-8/1/1 18-Jun-2013 62KCT08 3006005111 Aadivighnesh Chem PVT. LTD.
 
AYG-1002814-5/7/1 18-Jun-2013 35CFT99 3007646524 Swaraj Techno Engg. Pvt. Ltd.
 
KM6-0062820-0/8/6 19-Jun-2013 65SBO99 3009877732 Galaxy International
 
KM6-0062820-0/8/7 19-Jun-2013 65SBO99 3009877732 Galaxy International
 
KM6-0062820-0/12/1 19-Jun-2013 65RBZ18 3009877732 Galaxy International
 
RE9-0009429-3/6/1 21-Jun-2013 28BGT15 3005428233 Devi Exports Pvt Ltd
 
KM6-0127408-7/1/1 21-Jun-2013 02DGT07 3009858417 Sunstar Organic Food Private
 
EJ4-0008439-1/1/1 21-Jun-2013 02DGT07 13598 Amar Singh Chawalwala
 
112-2650029-2/8/1/E 21-Jun-2013 50NGY18 3005191745 Ishar Dass Amir Chand
 
D52-8914607-3/1/13 21-Jun-2013 37JEE99 3010148023 Anna Group of Companies
 
KM6-0061160-2/1/1 21-Jun-2013 02DAT07 2000024778 Bush Foods Overseas Pvt. Ltd.
 
AEK-9235221-6/1/1 24-Jun-2013 66VCY99 3010198335 P Ruth Grace
 
AEK-9227122-6/1/1 24-Jun-2013 53BY01 3008684202 Natures Natural India
 
KM6-0057596-3/5/1 24-Jun-2013 65RBZ18 3006344674 Pujan Enterprise
 
KM6-0127136-4/4/1 24-Jun-2013 28AGT19 3004270701 RAMDEV FOOD PRODUCTS PVT. LTD.
 
KM6-0127136-4/15/1 24-Jun-2013 33EGT99 3004270701 RAMDEV FOOD PRODUCTS PVT. LTD.
 
595-5040980-5/1/1 24-Jun-2013 16MGD09 3004317798 INTERNATIONAL FREEZFISH EXPORTS
 
595-5040980-5/2/1 24-Jun-2013 16MGD09 3004317798 INTERNATIONAL FREEZFISH EXPORTS
 
595-5036240-0/3/1 24-Jun-2013 16AGD29 3009998931 Everblue Seafoods Pvt. Ltd.
 
595-5036240-0/4/1 24-Jun-2013 16AGD29 3009998931 Everblue Seafoods Pvt. Ltd.
 
595-5036240-0/5/1 24-Jun-2013 16AGD29 3009998931 Everblue Seafoods Pvt. Ltd.
 
595-5036240-0/6/1 24-Jun-2013 16AGD29 3009998931 Everblue Seafoods Pvt. Ltd.
 
551-0686705-0/1/1 25-Jun-2013 62CCT10 3004373180 Unichem Laboratories Ltd
 
UPS-0591294-6/1/1 25-Jun-2013 54FER99 3003727907 Natural Remedies
 
G08-0028992-1/7/2 25-Jun-2013 50BGE60 3006632871 Topline Exim Inc.
 
AEK-0806125-7/1/1 25-Jun-2013 66VAY99 3010185914 Tsering Norbu
 
AEK-0800188-1/1/1 25-Jun-2013 66VAY99 3009619398 Genius Nature Herbs Pvt
 
793-0609240-8/1/1 25-Jun-2013 02DAY07 3004248774 Amira Pure Foods Private Limited
 
UPS-1200095-8/1/1 25-Jun-2013 55QY19 3010220426 Caxchem Corp
 
M21-0748096-6/1/1 25-Jun-2013 64LCA41 3007522260 Lyka Bdr International Ltd
 
M21-0748096-6/1/2 25-Jun-2013 64LCA41 3007522260 Lyka Bdr International Ltd
 
M21-0748096-6/1/3 25-Jun-2013 64LCA41 3007522260 Lyka Bdr International Ltd
 
9DN-0000563-5/1/1 25-Jun-2013 02DAE07 3008077089 Amir Chand Jagdish Kumar (Exports) Ltd.
 
281-0139001-2/33/1 26-Jun-2013 28AGT54 3007145073 Swad Foods India
 
JKL-0001337-7/2/1 26-Jun-2013 02DGY07 3009700896 Kevin Export
 
660-2515440-3/7/1 26-Jun-2013 05AGT01 2000027071 KITCHEN XPRESS OVERSEAS LIMITED
 
112-2131510-0/1/1 26-Jun-2013 76EAP 3010083795 Dhanwantari Medical Systems-Eb
 
H77-0135046-1/5/2 27-Jun-2013 53ED06 3007313144 Capital Ventures Pvt. Ltd.
 
KM6-0062842-4/20/8 27-Jun-2013 28KGT99 3004273165 Jhaveri Industries
 
BMG-0510389-3/13/1 27-Jun-2013 28BGT15 3009026486 Unique Fragrances
 
BMG-0510389-3/14/1 27-Jun-2013 28EGT04 3009026486 Unique Fragrances
 
U16-5328257-8/1/1 28-Jun-2013 02DGT02 3004328659 AABHAR INTERNATIONAL
 
U16-5328257-8/2/1 28-Jun-2013 02DGT02 3004328659 AABHAR INTERNATIONAL
 
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