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 | 3009510129 | O-G Nut Sales |
| 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 | Merch & 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 |
| 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 | 3004890986 | 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 | Wyeth Pharmaceuticals |
| 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 | Merch & 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 Healthcare 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 | Merch & Co Inc |
| 112-7500186-0/1/1/G | 29-Jun-2012 | 62ODK26 | 3004758118 | Merch & 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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