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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
112-9837194-3/1/1 01-Jun-2012 68BBB10 3003563645 Catalent Pharma Solutions, LLC
 
112-0384349-0/1/1 01-Jun-2012 86LPL 1000222023 Johnson & Johnson Vision Care, Inc.
 
112-0281363-5/1/1 01-Jun-2012 77KHL 2430101 Widex Hearing Aid
 
112-0193504-1/1/1 01-Jun-2012 68XIY99 3003563645 Catalent Pharma Solutions, LLC
 
113-5857793-7/1/1 04-Jun-2012 23AYH12 2935802 OG Packing Company
 
AEK-0278194-2/1/1 04-Jun-2012 80LDR 3002843564 Victus, Inc.
 
300-5651723-6/8/1 04-Jun-2012 64XAL06 1413063 Alberto Culver Co
 
300-5651723-6/31/1 04-Jun-2012 64XAL06 1413063 Alberto Culver Co
 
112-2320434-3/1/1 04-Jun-2012 66BCB19 2210396 Novartis Pharmaceuticals Corp.
 
112-2514026-3/1/1 04-Jun-2012 63EDA13 2518137 AstraZeneca Pharmaceuticals LP
 
112-3407216-8/1/1 04-Jun-2012 86HQY 3009053531 Usimprints Llc
 
231-5004675-7/1/1 06-Jun-2012 86HQL 3002023310 Tekia, Inc.
 
231-5004675-7/2/1 06-Jun-2012 86HQL 3002023310 Tekia, Inc.
 
231-5014854-6/1/1 06-Jun-2012 86HQL 3002023310 Tekia, Inc.
 
112-9314537-5/1/1 07-Jun-2012 62ODE24 1913298 Sanofi - Aventis US LLC
 
112-9442345-8/4/1 07-Jun-2012 55QP16 3004758118 Merck & Co Inc
 
508-0340126-9/7/20 07-Jun-2012 53LC03 2480525 Estee Lauder Inc
 
508-0340126-9/8/6 07-Jun-2012 53LC03 2480525 Estee Lauder Inc
 
508-0340126-9/8/12 07-Jun-2012 53LC03 2480525 Estee Lauder Inc
 
BUP-2527915-2/1/1 07-Jun-2012 57PH99 3001236616 Musculoskeletal Transplant Foundation
 
112-7135511-2/1/1 08-Jun-2012 65QAF22 3009493797 Baxter Healthcare
 
112-7185615-0/1/1 11-Jun-2012 74DRT 3003983663 Burdick Inc
 
112-7185850-3/1/1 11-Jun-2012 61LCZ32 2910913 Bayer Corporation
 
112-7383736-4/1/1 11-Jun-2012 53HH04 3008063607 Young Nails Inc
 
112-7383736-4/1/3 11-Jun-2012 53HH04 3008063607 Young Nails Inc
 
112-7383736-4/1/2 11-Jun-2012 53HH04 3008063607 Young Nails Inc
 
112-7383736-4/1/4 11-Jun-2012 53HH04 3008063607 Young Nails Inc
 
112-7383736-4/1/5 11-Jun-2012 53HH04 3008063607 Young Nails Inc
 
112-7383736-4/1/6 11-Jun-2012 53HH04 3008063607 Young Nails Inc
 
112-7383736-4/1/7 11-Jun-2012 53HH04 3008063607 Young Nails Inc
 
112-7383736-4/1/8 11-Jun-2012 53HH04 3008063607 Young Nails Inc
 
112-7383736-4/1/9 11-Jun-2012 53HH04 3008063607 Young Nails Inc
 
112-7383736-4/1/10/A 11-Jun-2012 53HH04 3008063607 Young Nails Inc
 
112-7383736-4/1/10/B 11-Jun-2012 53HH04 3008063607 Young Nails Inc
 
112-7383736-4/1/11 11-Jun-2012 53HH04 3008063607 Young Nails Inc
 
112-7383736-4/1/12 11-Jun-2012 53HH04 3008063607 Young Nails Inc
 
112-7383736-4/1/13 11-Jun-2012 53HH04 3008063607 Young Nails Inc
 
112-7383736-4/1/14 11-Jun-2012 53HH04 3008063607 Young Nails Inc
 
112-7383736-4/1/15 11-Jun-2012 53HH04 3008063607 Young Nails Inc
 
112-7383736-4/2/1 11-Jun-2012 53HD04 3008063607 Young Nails Inc
 
112-7383736-4/3/1 11-Jun-2012 53HD99 3008063607 Young Nails Inc
 
112-7383736-4/3/2 11-Jun-2012 53HD99 3008063607 Young Nails Inc
 
112-7383736-4/3/3 11-Jun-2012 53HD06 3008063607 Young Nails Inc
 
112-7383736-4/3/4 11-Jun-2012 53HD05 3008063607 Young Nails Inc
 
112-7383736-4/3/5 11-Jun-2012 53HH04 3008063607 Young Nails Inc
 
112-7383736-4/3/6 11-Jun-2012 53HD99 3008063607 Young Nails Inc
 
112-7383736-4/4/1 11-Jun-2012 53HY04 3008063607 Young Nails Inc
 
112-7383736-4/5/1 11-Jun-2012 53HD06 3008063607 Young Nails Inc
 
112-7383736-4/6/1 11-Jun-2012 53HJ04 3008063607 Young Nails Inc
 
112-7383736-4/9/1 11-Jun-2012 53HY99 3008063607 Young Nails Inc
 
112-7383736-4/10/1 11-Jun-2012 95RHW 3008063607 Young Nails Inc
 
112-7383736-4/7/1 11-Jun-2012 53HY99 3008063607 Young Nails Inc
 
112-7585288-1/1/1 11-Jun-2012 84GZI 1000384261 Sellex Incorporated
 
112-7952229-0/2/1 11-Jun-2012 86HKX 3008419080 Diaton
 
112-7003967-4/1/1 11-Jun-2012 73NFB 3008320514 Care One Home Medical Equipment
 
814-0197357-3/1/1 12-Jun-2012 57JH03 3001236616 Musculoskeletal Transplant Foundation
 
XXX-0286375-2/1/3 12-Jun-2012 1000135987 Delavau LLC
 
112-7707157-2/1/1 13-Jun-2012 74KRG 3001504994 Medtronic Inc
 
551-2018787-3/1/1 15-Jun-2012 54FBR99 3008566525 Raw Deal, Inc
 
112-5793345-2/1/2 15-Jun-2012 66MCK83 2416101 Pfizer Inc.
 
112-5793345-2/1/3 15-Jun-2012 64TCO08 1000036852 Astellas Pharma US Inc
 
112-5793345-2/1/1 15-Jun-2012 61HDK99 1000118068 Galderma Laboratories, L.P.
 
112-5751299-1/1/1 15-Jun-2012 66NCA02 3000123645 Eli Lilly And Company
 
112-6970905-5/1/1 18-Jun-2012 62UDA08 3008310124 Debra Sweeting
 
112-7124322-6/1/1 18-Jun-2012 95RFZ 3007499939 Datamax System Solutions
 
112-6041888-8/1/1 18-Jun-2012 66VIP99 3005343150 Berlex Laboratories Inc
 
112-6316404-2/1/1 18-Jun-2012 74DTL 1033554 DeRoyal Industries, Inc.
 
112-6365586-6/2/1 18-Jun-2012 78GCI 3011001078 Machida Inc
 
112-6630645-9/1/1 18-Jun-2012 56ICA76 3002173302 Pfizer Pharmaceuticals LLC
 
112-6989956-7/1/1 19-Jun-2012 61JDB08 3005894266 Pfizer
 
112-6989956-7/1/2 19-Jun-2012 61LDB38 3002482550 Briston Myers Squibb
 
112-6989956-7/1/3 19-Jun-2012 62TDB07 3004393730 Pfizer, Inc.
 
112-7761274-8/2/1 19-Jun-2012 66SCA51 2246315 Genzyme, Division of Sanofi Company
 
112-7761274-8/1/2 19-Jun-2012 89MOZ 2246315 Genzyme, Division of Sanofi Company
 
112-6060984-2/2/1/A 19-Jun-2012 95RFZ 1000524424 Intermec Corp
 
112-6060984-2/2/1/B 19-Jun-2012 95RFZ 3000126713 Cognex Corp
 
112-6822035-1/1/1 20-Jun-2012 86HQG 3008093784 Profit Optix
 
112-6823448-5/2/1 20-Jun-2012 79KMF 1000252221 Kendall Healthcare
 
112-6834933-3/1/1 20-Jun-2012 74KRI 3006452343 Nellcor Puritan Bennett Inc
 
112-6834933-3/1/2 20-Jun-2012 78MSD 3008269645 Sherwood Medical Co
 
112-6834933-3/1/3 20-Jun-2012 73JOH 1925021 Mallinckrodt Inc
 
112-6834933-3/1/4 20-Jun-2012 73CCK 3005484778 Ussc Group Inc
 
112-6834933-3/1/5 20-Jun-2012 79GCJ 3008269644 Endoscopic Concepts
 
112-6834933-3/1/6 20-Jun-2012 79GAQ 1210157 Davis & Geck, Inc.
 
112-6871083-1/1/1 20-Jun-2012 63BAL25 1035048 GlaxoSmithKline
 
112-7292922-9/1/1 20-Jun-2012 66VIP99 3001451366 Banner Pharmacaps Inc.
 
112-7440143-3/1/1 20-Jun-2012 64GDA07 3008057462 Bar Pharmaceuticals
 
112-6613795-3/1/1 20-Jun-2012 86HQY 3008107041 Ultra Palm Optical
 
112-7204112-4/1/1 20-Jun-2012 87MJO 3002980729 NuVasive Inc
 
112-5421503-5/1/1 20-Jun-2012 79KKX 3001675293 Intuitive Surgical, Inc.
 
112-5426927-1/1/1 20-Jun-2012 86HQG 3008333104 Essilor America
 
112-5500307-5/1/1 20-Jun-2012 61ECA09 3004758118 Merck & Co Inc
 
112-5536967-4/1/1 20-Jun-2012 62DCB02 2026154 Amgen, Inc.
 
M42-1250729-5/1/1 20-Jun-2012 23AYB11 3004270789 Primex Farms, LLC.
 
XXX-0178155-9/1/1 21-Jun-2012 66VAY99 3009560119 GBTRx, Inc
 
322-0707772-2/1/1 21-Jun-2012 64LAK20 3000314035 Pharmacia & Upjohn Worldwide
 
231-3763380-0/1/1 25-Jun-2012 56JCK31 3000314035 Pharmacia & Upjohn Worldwide
 
AJY-0223482-0/1/1 26-Jun-2012 23BAB07 3009563834 Mccleskey Mills
 
UPS-3568368-3/1/1 26-Jun-2012 90IZL 1218950 Philips Medical Systems, Inc.
 
DM0-0941789-8/2/1 28-Jun-2012 23YYY99 2939582 Setton Pistachio of Terra Bella, Inc.
 
112-7681809-8/1/1 29-Jun-2012 38AWN04 3006643119 IPMF LLC dba IPM Foods
 
112-7681809-8/1/2 29-Jun-2012 38AWN13 3006643119 IPMF LLC dba IPM Foods
 
112-7830623-3/1/1 29-Jun-2012 89MNE 3009567201 Prothetic Onthotic
 
UPS-5356685-3/1/1 29-Jun-2012 53LD01 3009404666 Zo Skin
 
UPS-5356685-3/1/2 29-Jun-2012 64XAY06 3009404666 Zo Skin
 
UPS-5356685-3/1/3 29-Jun-2012 53LD06 3009404666 Zo Skin
 
UPS-5356685-3/1/4 29-Jun-2012 53LD06 3009404666 Zo Skin
 
UPS-5356685-3/1/5 29-Jun-2012 53LD06 3009404666 Zo Skin
 
UPS-5356685-3/1/6 29-Jun-2012 53LD06 3009404666 Zo Skin
 
UPS-5356685-3/1/9 29-Jun-2012 66PBY99 3009404666 Zo Skin
 
UPS-5356685-3/1/15 29-Jun-2012 65LBL11 3009404666 Zo Skin
 
UPS-5356685-3/1/16 29-Jun-2012 65LBL11 3009404666 Zo Skin
 
112-7500186-0/1/1/A 29-Jun-2012 65KCK10 1643525 Allergan Sales, LLC
 
112-7500186-0/1/1/F 29-Jun-2012 62ODK26 3004758118 Merck & Co Inc
 
112-7500186-0/1/1/G 29-Jun-2012 62ODK26 3004758118 Merck & Co Inc
 
112-7509309-9/1/1/A 29-Jun-2012 66SCA28 3006463165 Parke-Davis
 
112-7509309-9/1/1/B 29-Jun-2012 62OCA15 2517175 Teva Pharmaceuticals USA, Inc.
 
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