• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Import Refusal Report

  • Print
  • Share
  • E-mail
-

Refusal Actions by FDA as Recorded in OASIS

for United States


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
470-0083059-7/1/1 03-Sep-2013 76DZN 3004438200 3m Espe Division
 
609-0328069-5/2/1 04-Sep-2013 79NAD 1049092 Convatec, A Bristol-Myers Squibb Co.
 
609-0328069-5/1/1 04-Sep-2013 79NAD 1049092 Convatec, A Bristol-Myers Squibb Co.
 
609-0328069-5/3/1 04-Sep-2013 80NZI 1049092 Convatec, A Bristol-Myers Squibb Co.
 
609-0328069-5/4/1 04-Sep-2013 80NZI 1049092 Convatec, A Bristol-Myers Squibb Co.
 
609-0328069-5/5/1 04-Sep-2013 80NZI 1049092 Convatec, A Bristol-Myers Squibb Co.
 
609-0328069-5/6/1 04-Sep-2013 80NZI 1049092 Convatec, A Bristol-Myers Squibb Co.
 
609-0328316-0/2/1 04-Sep-2013 80NZI 1049092 Convatec, A Bristol-Myers Squibb Co.
 
609-0328316-0/3/1 04-Sep-2013 80NZI 1049092 Convatec, A Bristol-Myers Squibb Co.
 
609-0328316-0/1/1 04-Sep-2013 79NAD 1049092 Convatec, A Bristol-Myers Squibb Co.
 
112-3699326-3/1/1 05-Sep-2013 75NBW 3009602783 Georgetown Management Inc.
 
BNW-0134583-5/19/1 05-Sep-2013 86HQY 3005715538 Duty Free Air And Ship Supply Co
 
WFN-8233831-6/31/1 09-Sep-2013 31MDH99 2517715 The East Indies Company
 
WFN-8235622-7/54/1 09-Sep-2013 31KGH01 2517715 The East Indies Company
 
E4G-0008572-0/2/3/A 09-Sep-2013 53HY99 3003476273 Young Nails Inc
 
WX5-0181503-8/6/2 10-Sep-2013 79KGX 3002750084 Aspen Surgical Products, Inc.
 
FY6-2008413-4/1/1 13-Sep-2013 75CGA 2939301 Lifescan Inc
 
J50-0138601-8/1/1 13-Sep-2013 53LH09 3007948317 Radical Cosmetics
 
AA8-0025560-3/2/1 16-Sep-2013 74MKJ 3015876 Physio-Control, Inc.
 
AA8-0025560-3/1/1 16-Sep-2013 74DXT 2520313 Medrad Inc dba Bayer R&I
 
UPS-1612388-9/1/1 16-Sep-2013 53LD06 3010275482 Optigenex
 
UPS-1612388-9/1/2 16-Sep-2013 53LD06 3010275482 Optigenex
 
UPS-1612388-9/1/3 16-Sep-2013 53CC04 3010275482 Optigenex
 
R12-0047022-6/2/1 17-Sep-2013 86HQY 2083323 Oakley Inc
 
R12-0047022-6/5/1 17-Sep-2013 86HQY 2083323 Oakley Inc
 
XXX-0182182-7/3/180/A 18-Sep-2013 79NRJ 3002087856 SonoSite, Inc.
 
XXX-0182182-7/3/180/B 18-Sep-2013 79NRJ 3002087856 SonoSite, Inc.
 
609-0328347-5/1/1 19-Sep-2013 79KGX 3006256586 3m Company
 
112-3763349-6/1/1 20-Sep-2013 88LDT 2083595 Smart Health Inc. (dba) SmartPractice
 
799-0622825-3/1/1 20-Sep-2013 86LPL 1053053 Alcon Laboratories, Inc
 
799-0433124-0/1/1 23-Sep-2013 90ITX 1000124215 Interson Corp
 
799-0533300-5/2/1 23-Sep-2013 79GEI 3010343867 Cdw
 
799-0533300-5/2/2 23-Sep-2013 79GEI 3010343866 Allied Electronics
 
EE1-0043086-1/1/1 23-Sep-2013 54YBT01 3004334067 Klamath Valley Botanicals
 
739-7028044-9/1/1 26-Sep-2013 23AGT01 3010281181 Mt Trading Co
 
9BM-0016961-8/1/1 27-Sep-2013 68YYY99 3008820514 Azmira Holistic Animal Care
 
9BM-0016961-8/2/1 27-Sep-2013 68YYY99 3008820514 Azmira Holistic Animal Care
 
9BM-0016961-8/3/1 27-Sep-2013 68YYY99 3008820514 Azmira Holistic Animal Care
 
9BM-0016961-8/4/1 27-Sep-2013 68YYY99 3008820514 Azmira Holistic Animal Care
 
9BM-0016961-8/5/1 27-Sep-2013 68YYY99 3008820514 Azmira Holistic Animal Care
 
9BM-0016961-8/6/1 27-Sep-2013 68YYY99 3008820514 Azmira Holistic Animal Care
 
9BM-0016961-8/7/1 27-Sep-2013 68YYY99 3008820514 Azmira Holistic Animal Care
 
9BM-0016961-8/8/1 27-Sep-2013 68YYY99 3008820514 Azmira Holistic Animal Care
 
9BM-0016961-8/9/1 27-Sep-2013 68YYY99 3008820514 Azmira Holistic Animal Care
 
9BM-0016961-8/10/1 27-Sep-2013 68JYY99 3008820514 Azmira Holistic Animal Care
 
9BM-0016961-8/11/1 27-Sep-2013 68YYY99 3008820514 Azmira Holistic Animal Care
 
9BM-0016961-8/12/1 27-Sep-2013 68YYY99 3008820514 Azmira Holistic Animal Care
 
9BM-0016961-8/13/1 27-Sep-2013 68YYY99 3008820514 Azmira Holistic Animal Care
 
9BM-0016961-8/14/1 27-Sep-2013 68YYY99 3008820514 Azmira Holistic Animal Care
 
9BM-0016961-8/15/1 27-Sep-2013 68YYY99 3008820514 Azmira Holistic Animal Care
 
9BM-0016961-8/16/1 27-Sep-2013 68YYY99 3008820514 Azmira Holistic Animal Care
 
9BM-0016961-8/17/1 27-Sep-2013 68YYY99 3008820514 Azmira Holistic Animal Care
 
9BM-0016961-8/18/1 27-Sep-2013 68YYY99 3008820514 Azmira Holistic Animal Care
 
9BM-0016961-8/19/1 27-Sep-2013 68YYY99 3008820514 Azmira Holistic Animal Care
 
9BM-0016961-8/20/1 27-Sep-2013 68YYY99 3008820514 Azmira Holistic Animal Care
 
9BM-0016961-8/21/1 27-Sep-2013 68YYY99 3008820514 Azmira Holistic Animal Care
 
9BM-0016961-8/22/1 27-Sep-2013 68YYY99 3008820514 Azmira Holistic Animal Care
 
9BM-0016961-8/23/1 27-Sep-2013 68YYY99 3008820514 Azmira Holistic Animal Care
 
9BM-0016961-8/24/1 27-Sep-2013 68YYY99 3008820514 Azmira Holistic Animal Care
 
9BM-0016961-8/25/1 27-Sep-2013 68YYY99 3008820514 Azmira Holistic Animal Care
 
9BM-0016961-8/26/1 27-Sep-2013 68YYY99 3008820514 Azmira Holistic Animal Care
 
799-0572782-6/2/2 27-Sep-2013 65LAL11 3009406796 Beauty Health & Science Innovations Inc
 
799-0552870-3/1/1 27-Sep-2013 87HRX 1017294 Linvatec Corp. dba ConMed Linvatec
 
799-0518904-3/1/1 27-Sep-2013 76EBG 3010341343 Kerr Usa
 
799-1030997-4/1/1 27-Sep-2013 89ONH 3007972617 Tri Tech Manufacturing
 
UPS-0741888-4/2/1 27-Sep-2013 66V99 3007171192 USPlabs, LLC
 
799-0729683-8/1/1 30-Sep-2013 65LBJ99 1025442 Aubrey Organics, Inc.
 
799-0729683-8/1/2 30-Sep-2013 65LBJ99 1025442 Aubrey Organics, Inc.
 
799-0416920-2/2/3 30-Sep-2013 65ACH04 3008511675 Forest Pharmaceuticals Nc
 
799-0416920-2/2/1 30-Sep-2013 65ACH04 3008511675 Forest Pharmaceuticals Nc
 
799-0416920-2/2/2 30-Sep-2013 65ACH04 3008511675 Forest Pharmaceuticals Nc
 
799-0416920-2/2/4 30-Sep-2013 65ACH04 3008511675 Forest Pharmaceuticals Nc
 
429-0779840-1/1/2 30-Sep-2013 16AGT51 3009163402 Thomas Calvert & Associates
 
429-0779840-1/1/3 30-Sep-2013 16AGT45 3009163402 Thomas Calvert & Associates
 
429-0779840-1/1/1 30-Sep-2013 16AGT54 3009163402 Thomas Calvert & Associates
 
-
-