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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 80-General Hospital/Personal Use


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
DM9-6011636-4/1/1 22-Dec-2006 80FLE 3002997873 Fanem Ltda Brazil
 
101-7247675-5/1/1 06-Dec-2006 80FMC 3002808247 Sri Johani Sdn Bhd Malaysia
 
101-7247675-5/1/2 06-Dec-2006 80FMC 3002808247 Sri Johani Sdn Bhd Malaysia
 
112-3619153-4/3/1 19-Dec-2006 80FMC 3002921500 Flexitech SDN BHd Malaysia
 
112-3619153-4/3/2 19-Dec-2006 80FMC 3002921500 Flexitech SDN BHd Malaysia
 
112-3619153-4/3/3 19-Dec-2006 80FMC 3002921500 Flexitech SDN BHd Malaysia
 
112-3903975-5/1/1 04-Dec-2006 80FOZ 1000322222 Medex Medical Inc United Kingdom
 
JF7-0052440-4/1/1 28-Dec-2006 80FOZ 3006044050 Suru International Pvt Ltd. India
 
JF7-0052440-4/1/2 28-Dec-2006 80FOZ 3006044050 Suru International Pvt Ltd. India
 
315-8154254-0/1/1 21-Dec-2006 80FPL 3005322529 Hissin Medizintechnik Gmbh Germany
 
112-4312279-5/1/1 12-Dec-2006 80FQM 3004096641 K J I Industrial Co., Ltd. Korea, Republic Of (South)
 
315-8154254-0/3/1 21-Dec-2006 80KMI 3005322529 Hissin Medizintechnik Gmbh Germany
 
551-6151859-7/10/1 06-Dec-2006 80KYP 3000119529 Coghlan's Ltd. Canada
 
315-8154254-0/5/1 21-Dec-2006 80KYX 3005322529 Hissin Medizintechnik Gmbh Germany
 
112-2929793-4/1/1 12-Dec-2006 80KYZ 1000237889 Kam Fung Metal Manufactory China
 
EQ6-0005583-2/1/1 12-Dec-2006 80LDQ 5833 EPPENDORF AG Germany
 
112-4352232-5/1/1 22-Dec-2006 80LDQ 3006035743 Best Green Co Ltd Korea, Republic Of (South)
 
554-3570087-1/1/1 13-Dec-2006 80LEY 3006946044 WELL-LEAD TRADING CO., LTD China
 
554-3570087-1/1/2 13-Dec-2006 80LEY 3006946044 WELL-LEAD TRADING CO., LTD China
 
554-3570087-1/1/3 13-Dec-2006 80LEY 3006946044 WELL-LEAD TRADING CO., LTD China
 
554-3570087-1/1/4 13-Dec-2006 80LEY 3006946044 WELL-LEAD TRADING CO., LTD China
 
554-3570087-1/1/5 13-Dec-2006 80LEY 3006946044 WELL-LEAD TRADING CO., LTD China
 
554-3570087-1/1/6 13-Dec-2006 80LEY 3006946044 WELL-LEAD TRADING CO., LTD China
 
554-3570087-1/1/7 13-Dec-2006 80LEY 3006946044 WELL-LEAD TRADING CO., LTD China
 
554-3570087-1/1/8 13-Dec-2006 80LEY 3006946044 WELL-LEAD TRADING CO., LTD China
 
554-3570087-1/1/9 13-Dec-2006 80LEY 3006946044 WELL-LEAD TRADING CO., LTD China
 
554-3570087-1/1/10 13-Dec-2006 80LEY 3006946044 WELL-LEAD TRADING CO., LTD China
 
554-3570087-1/1/11 13-Dec-2006 80LEY 3006946044 WELL-LEAD TRADING CO., LTD China
 
525-0725897-9/1/1 01-Dec-2006 80LYY 3003116055 Comfort Rubber Gloves Industries Sdn. Bhd. Malaysia
 
433-0936678-9/1/2 14-Dec-2006 80LYY 3183 Marcon Rubber Industry Malaysia
 
433-0936678-9/1/1 14-Dec-2006 80LYY 3183 Marcon Rubber Industry Malaysia
 
231-4760927-8/1/4 06-Dec-2006 80LYZ 3004168786 Grand Work Plastic Products Co., Ltd. China
 
231-4760927-8/1/5 06-Dec-2006 80LYZ 3004168786 Grand Work Plastic Products Co., Ltd. China
 
231-4760927-8/1/6 06-Dec-2006 80LYZ 3004168786 Grand Work Plastic Products Co., Ltd. China
 
231-4760927-8/1/7 06-Dec-2006 80LYZ 3004168786 Grand Work Plastic Products Co., Ltd. China
 
231-4760927-8/1/8 06-Dec-2006 80LYZ 3004168786 Grand Work Plastic Products Co., Ltd. China
 
231-4760927-8/1/9 06-Dec-2006 80LYZ 3004168786 Grand Work Plastic Products Co., Ltd. China
 
231-1209638-6/1/1 11-Dec-2006 80LYZ 3003852635 Shanghai Foremost Plastic Industrial Co., Ltd. China
 
231-1209638-6/1/2 11-Dec-2006 80LYZ 3003852635 Shanghai Foremost Plastic Industrial Co., Ltd. China
 
231-1209638-6/1/3 11-Dec-2006 80LYZ 3003852635 Shanghai Foremost Plastic Industrial Co., Ltd. China
 
231-1209638-6/1/4 11-Dec-2006 80LYZ 3003852635 Shanghai Foremost Plastic Industrial Co., Ltd. China
 
231-1209638-6/1/5 11-Dec-2006 80LYZ 3003852635 Shanghai Foremost Plastic Industrial Co., Ltd. China
 
H77-0102628-5/1/1 20-Dec-2006 80LYZ 3003857909 Shanghai Champion Plastic Products Co., Ltd. China
 
FR1-0011649-5/2/1 11-Dec-2006 80MIA 3000247873 Nipro Corporation Japan
 
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