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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 United States


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
CDF-0039738-3/1/1/A 05-Jan-2012 66YBY99 1250045 Tender Corporation
 
CDF-0039738-3/1/1/B 05-Jan-2012 66YBY99 1250045 Tender Corporation
 
112-9349532-5/1/1 05-Jan-2012 64UCS99 1826582 Albemarle Corporation
 
WC1-8453455-8/107/1 06-Jan-2012 74DQO 1721504 Merit Medical Systems, Inc.
 
112-7559822-9/1/1 06-Jan-2012 86HQZ 3005097582 Csc Labs
 
112-7559822-9/1/2 06-Jan-2012 86HQZ 3006068575 Tuscany Eyewear
 
112-7559822-9/2/1 06-Jan-2012 86HQZ 3005097582 Csc Labs
 
112-7559822-9/2/2 06-Jan-2012 86HQZ 3006068575 Tuscany Eyewear
 
WC1-8458491-8/5/1 06-Jan-2012 87HRR 1450901 Technicality Inc.
 
WC1-8452844-4/3/1 06-Jan-2012 79HTD 1450901 Technicality Inc.
 
WC1-8452844-4/4/1 06-Jan-2012 79HTD 1450901 Technicality Inc.
 
WC1-8452844-4/5/1 06-Jan-2012 87HRR 1450901 Technicality Inc.
 
WC1-8452844-4/97/1 06-Jan-2012 87HRR 1450901 Technicality Inc.
 
WC1-8452844-4/98/1 06-Jan-2012 79HTD 1450901 Technicality Inc.
 
WC1-8452844-4/136/1 06-Jan-2012 78FHQ 1450901 Technicality Inc.
 
WC1-8452844-4/138/1 06-Jan-2012 79HTD 1450901 Technicality Inc.
 
112-7344949-0/1/1 06-Jan-2012 80MQT 3006177174 Curlin Medical
 
112-9196840-6/1/1 06-Jan-2012 56BCK52 1000208638 King Legacy, a wholly owned subsidiary of Pfizer
 
112-9941426-2/1/1 06-Jan-2012 61PCA02 3002393210 Takeda Pharmaceuticals North America, Inc.
 
112-5606953-9/1/1 07-Jan-2012 79GFG 3006179409 Orchid Unique
 
112-6812464-5/2/1 07-Jan-2012 79OHO 3008292589 Whistle Creek
 
112-8140210-1/1/1 07-Jan-2012 73DQA 3008346242 Medical Device Depot Inc
 
112-6866886-4/1/1 07-Jan-2012 78MRE 3008299451 Victor Labbate Md
 
WC1-8454779-0/78/1 10-Jan-2012 87HRR 1450901 Technicality Inc.
 
WC1-8454779-0/79/1 10-Jan-2012 79HTD 1450901 Technicality Inc.
 
814-0192197-8/1/1 11-Jan-2012 60KIK99 3005204557 Merck and Company
 
112-4781367-3/1/1 11-Jan-2012 77KHL 2125608 Starkey Laboratories,Inc
 
112-8389937-9/2/1 12-Jan-2012 64GCA07 2244771 Novo Nordisk, Inc.
 
112-7170482-1/1/1 12-Jan-2012 95RFZ 3003498769 Versatile Mobile Sys
 
112-7238218-9/1/1 12-Jan-2012 87LXH 1219518 Holmed Corporation
 
112-7238218-9/1/2 12-Jan-2012 87HXB 3002993297 Norwood Tool Co
 
112-7238218-9/1/3 12-Jan-2012 87HWR 3008125932 Micropulse Inc
 
112-7330403-4/2/1 13-Jan-2012 64AAL20 3008351740 Lovehoney
 
112-5484225-0/1/1 17-Jan-2012 74DXT 3004056159 Medrad, Inc. dba Bayer R&I
 
AL6-0051476-7/1/1 17-Jan-2012 75LZX 2050011 Beckman Coulter Inc
 
W13-4250737-5/1/1 17-Jan-2012 24HYY50 3003222763 John Potter Specialty Foods Inc
 
GEO-6403109-5/1/1 18-Jan-2012 66VCY99 1000132620 Holland America Line -
 
BJE-0118704-7/2/1 20-Jan-2012 65HCN04 1628454 Hospira, Inc.
 
UPS-4359610-1/1/1/A 20-Jan-2012 53LC03 3006299581 Max International, LLC
 
UPS-4359610-1/1/1/B 20-Jan-2012 53LC03 3006299581 Max International, LLC
 
UPS-4359610-1/1/1/C 20-Jan-2012 53LC03 3006299581 Max International, LLC
 
UPS-4359610-1/1/1/D 20-Jan-2012 53LC03 3006299581 Max International, LLC
 
UPS-4359610-1/1/1/E 20-Jan-2012 53LC03 3006299581 Max International, LLC
 
938-0070958-1/1/1 20-Jan-2012 54FCY43 3009183303 Pacific Meridian Technologies, Inc
 
112-5457800-3/1/1 20-Jan-2012 86HOY 1000120804 Burlington Medical Supplies Inc
 
112-5522373-2/2/1 20-Jan-2012 87JDZ 2027467 Alphatec Spine, Inc.
 
112-5522373-2/3/1 20-Jan-2012 78KNW 2027467 Alphatec Spine, Inc.
 
AWJ-0111259-3/1/2 23-Jan-2012 54FCH99 3006585960 Applied Nutrition
 
AWJ-0111259-3/1/3 23-Jan-2012 65VAA99 1811666 L. Perrigo Co.
 
AWJ-0111259-3/1/10 23-Jan-2012 66VDY99 3006278664 Newton Everett
 
AWJ-0111259-3/1/31 23-Jan-2012 62CBL41 3009218807 DS Laboratories
 
AWJ-0111259-3/1/32 23-Jan-2012 62CBL41 3005622610 Costco Wholesale Corporation
 
AV3-0024003-1/1/3 24-Jan-2012 64XBJ06 1000526880 Reckitt Benckiser Inc
 
UPS-4467326-3/1/2 24-Jan-2012 54YEE99 3009242137 Life Extension Nutrition Center
 
UPS-4467326-3/1/13 24-Jan-2012 54YEE99 3009242137 Life Extension Nutrition Center
 
UPS-4467326-3/1/19 24-Jan-2012 54YEE99 3009242137 Life Extension Nutrition Center
 
GEO-6403147-5/1/1 24-Jan-2012 80FRN 1416980 Baxter Healthcare Corp.
 
GEO-6403148-3/1/1 24-Jan-2012 66VCY99 1000135041 Bellegrove Medical Supply
 
AEK-8620348-2/1/1 25-Jan-2012 61PAA55 3003596612 Sanofi-Aventis U.S. LLC
 
AEK-8620348-2/2/1 25-Jan-2012 62OAA37 3003596612 Sanofi-Aventis U.S. LLC
 
UPS-3808723-9/1/1 26-Jan-2012 73DQA 3008859522 Mack Medical Company
 
AEK-8622239-1/1/1 27-Jan-2012 82DCF 3000121413 Baxter Healthcare Corporation
 
551-9515111-8/1/1 31-Jan-2012 53JD99 1519202 Woodbine Products Co Inc
 
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