• 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 80-General Hospital/Personal Use


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
T94-0028939-1/7/1 06-May-2003 80FLK 3003379018 Shanghai Jiu He Import And Export Co. China
 
T94-0030422-4/8/1 01-May-2003 80FLL 3003379018 Shanghai Jiu He Import And Export Co. China
 
T94-0031181-5/8/1 28-May-2003 80FLL 3003379018 Shanghai Jiu He Import And Export Co. China
 
T94-0030422-4/7/1 01-May-2003 80FMA 3003379018 Shanghai Jiu He Import And Export Co. China
 
T94-0028939-1/3/1 06-May-2003 80FMA 3003379018 Shanghai Jiu He Import And Export Co. China
 
T94-0031181-5/1/1 28-May-2003 80FMA 3003379018 Shanghai Jiu He Import And Export Co. China
 
224-0333936-3/1/7 01-May-2003 80FMF 1118880 Terumo Medical Corporation United States
 
224-0333936-3/1/8 01-May-2003 80FMI 1118880 Terumo Medical Corporation United States
 
224-0333936-3/1/9 01-May-2003 80FMI 2243072 Becton Dickinson & Company United States
 
AN1-0314485-1/1/1 07-May-2003 80FMI 3003983545 Korea Vaccine Company, Ltd. Korea, Republic Of (South)
 
T94-0030422-4/5/1 01-May-2003 80FOZ 3003379018 Shanghai Jiu He Import And Export Co. China
 
T94-0031181-5/3/1 28-May-2003 80FOZ 3003379018 Shanghai Jiu He Import And Export Co. China
 
T94-0031181-5/12/1 28-May-2003 80FOZ 3003379018 Shanghai Jiu He Import And Export Co. China
 
667-0063089-1/1/1 02-May-2003 80FQM 1000551437 White Medical Ind., Inc. Korea, Republic Of (South)
 
457-0039197-7/1/1 20-May-2003 80FQM 1000551437 White Medical Ind., Inc. Korea, Republic Of (South)
 
548-0112195-2/5/1 27-May-2003 80FQM 3003820664 Zhivotovsky Vladimir Shikovich Russia
 
D77-0354028-7/1/1 23-May-2003 80JOK 1000144275 Dagger Industries Pakistan
 
112-0436362-6/1/1 30-May-2003 80KGX 3003987956 Napier Quill Limited United Kingdom
 
T94-0030422-4/6/1 01-May-2003 80KZH 3003379018 Shanghai Jiu He Import And Export Co. China
 
112-2280665-4/1/1 01-May-2003 80KZH 2246315 Genzyme, Division of Sanofi Company United States
 
310-5275747-8/1/1 08-May-2003 80LDQ 3002117852 Koolatron Div Urus Indus Canada
 
112-0501892-2/1/1 16-May-2003 80LDQ 3003347293 Q-Med AB Sweden
 
112-0501928-4/1/1 16-May-2003 80LDQ 3003347293 Q-Med AB Sweden
 
AD3-0179745-3/3/1 17-May-2003 80LDQ 3002772325 Chinalight Tri-Union Int'l. Co., Ltd. China
 
112-0679789-6/1/1 20-May-2003 80LDQ 3003978414 H B Link Enterprise Malaysia
 
112-0700687-5/1/1 27-May-2003 80LDQ 3003978414 H B Link Enterprise Malaysia
 
112-0717602-5/1/1 27-May-2003 80LDQ 3003978414 H B Link Enterprise Malaysia
 
112-0633940-0/1/1 29-May-2003 80LDQ 3003371891 Glenmore Landing Dentis Canada
 
322-6296406-0/1/1 27-May-2003 80LLI 3003817015 Bed'S & Moore Germany
 
224-0333936-3/1/14 01-May-2003 80LYY 3003015706 Majestic Aerotech Inc. United States
 
GL5-0687428-5/5/1 16-May-2003 80LYY 3003755890 Synex Healthcare Products Company Limited China
 
002-1121252-7/1/1 08-May-2003 80LYZ 3003851053 Zi Bo Hong Wang Plastic & Rubber Products Co., Ltd. China
 
484-2006050-0/4/1 14-May-2003 80LZA 3000287381 Supermax Sdn Bhd Malaysia
 
582-0451951-6/1/1 23-May-2003 80LZA 3002622625 Lohmann & Rauscher Gmbh & Cokg Germany
 
551-2413941-6/2/1/A 01-May-2003 80MDS 3003669813 Bayer United States
 
551-2413941-6/2/1/B 01-May-2003 80MDS 3003669813 Bayer United States
 
551-2413941-6/4/1 01-May-2003 80MDS 1823260 Roche Diagnostics Operations, Inc. United States
 
FR1-0010790-8/2/1 01-May-2003 80MIA 1000258417 Nissho Corporation Japan
 
T94-0031181-5/11/1 28-May-2003 80MRZ 3003379018 Shanghai Jiu He Import And Export Co. China
 
AN1-0314485-1/2/1 07-May-2003 80MWV 3003983545 Korea Vaccine Company, Ltd. Korea, Republic Of (South)
 
XXX-0055204-3/1/1 15-May-2003 80NGT 3003837939 Max X Enterprise Canada
 
-
-