Import Refusal Report
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Refusal Actions by FDA as Recorded in OASIS
for Japan
| Entry/doc/line/sfx | Refusal Date | Product Code |
Manufacturer FEI |
Manufacturer Name |
|---|---|---|---|---|
| 221-1955137-6/52/1 | 02-Aug-2011 | 16AGH01 | 3007307828 | Sakamoto Co., Ltd. |
| 597-0164640-4/10/2 | 04-Aug-2011 | 66VBY99 | 3005219041 | Tomofuji Shoji Co., Ltd |
| 112-7306095-8/1/1 | 05-Aug-2011 | 85MQL | 3007530035 | Kitazato Biopharma |
| 112-6262735-3/1/1 | 05-Aug-2011 | 54EDA99 | 1000320824 | Mitsui Norin Co Ltd |
| 112-7185769-4/1/1 | 05-Aug-2011 | 95RDW | 3004560040 | Santec Corporation. |
| 112-7250513-6/1/1 | 08-Aug-2011 | 86HQY | 3005737816 | Ena Optical Manufacturing Co. |
| 510-6899667-0/1/1 | 09-Aug-2011 | 55RP46 | 2000014916 | Nihon Shokuhin Kako Co., Ltd. Fuji Plant |
| 510-6899673-8/1/1 | 09-Aug-2011 | 61WIZ38 | 3004556509 | Yuki Gosei Kogyo Co. Ltd. |
| 417-0275331-4/111/1 | 10-Aug-2011 | 33EGT99 | 3002522606 | Marugen Ltd. |
| 906-1082475-8/5/1 | 12-Aug-2011 | 37JCE05 | 3004662811 | KIKKOMAN CO., LTD. |
| 906-1082475-8/6/1 | 12-Aug-2011 | 37JEE05 | 3004662811 | KIKKOMAN CO., LTD. |
| 906-1082475-8/37/1 | 12-Aug-2011 | 37JHO99 | 3004319527 | HIGETA SHOYU CO., CHOSHI PLANT |
| 906-1082475-8/39/1 | 12-Aug-2011 | 37JHP07 | 3003532551 | Nippon Del Monte Gunma Plant |
| 906-1082475-8/40/1 | 12-Aug-2011 | 37JHE99 | 3003532551 | Nippon Del Monte Gunma Plant |
| 286-1653111-8/2/1 | 15-Aug-2011 | 86NQE | 3002680900 | Tomey Corporation |
| 286-1653111-8/3/1 | 15-Aug-2011 | 86NFI | 3002680900 | Tomey Corporation |
| 286-1653111-8/1/1 | 15-Aug-2011 | 86MMQ | 3002680900 | Tomey Corporation |
| 286-1653111-8/5/1 | 15-Aug-2011 | 86NFI | 3002680900 | Tomey Corporation |
| 286-1653111-8/4/1 | 15-Aug-2011 | 86NFI | 3002680900 | Tomey Corporation |
| E4K-0043634-0/1/1 | 15-Aug-2011 | 16AVC79 | 3008649230 | Koyo Trading Ltd |
| 224-1156361-6/6/2 | 15-Aug-2011 | 37JHT07 | 3003216300 | Daisho Co., Ltd. - Fukuoka Factory |
| 221-1950010-0/78/1 | 17-Aug-2011 | 37JHE99 | 9201 | Bulldog Sauce Co Ltd Hatogaya Factory |
| 221-1950010-0/79/1 | 17-Aug-2011 | 37JHE99 | 9201 | Bulldog Sauce Co Ltd Hatogaya Factory |
| 221-1950010-0/80/1 | 17-Aug-2011 | 24BEE19 | 2000045360 | Hashimoto Foods Co., Ltd. |
| D21-0053108-8/1/1 | 18-Aug-2011 | 86HPT | 3003664652 | Inami & Company Ltd |
| F23-9048850-0/1/1 | 23-Aug-2011 | 53LH03 | 3009037052 | Cosmetexroland Co Ltd |
| F23-9048850-0/2/1 | 23-Aug-2011 | 53KC01 | 3009037052 | Cosmetexroland Co Ltd |
| F23-9048850-0/3/1 | 23-Aug-2011 | 53ED06 | 3009037052 | Cosmetexroland Co Ltd |
| 112-2123917-6/1/1 | 23-Aug-2011 | 86HQG | 3003996146 | Ikentani Company |
| 112-2052341-4/1/1 | 23-Aug-2011 | 79GAO | 3003600988 | Medical U & A Inc |
| 112-2052341-4/1/2 | 23-Aug-2011 | 79HXD | 3003600988 | Medical U & A Inc |
| 112-1608094-0/1/1 | 23-Aug-2011 | 85MQK | 3007530035 | Kitazato Biopharma |
| 112-1454294-1/1/1 | 23-Aug-2011 | 85MQL | 3007530035 | Kitazato Biopharma |
| 112-1483625-1/1/1 | 23-Aug-2011 | 53YY99 | 1000378201 | Rohto Pharmaceutical Co., Ltd. |
| 112-0738493-9/1/1 | 23-Aug-2011 | 86HQY | 3007848014 | Paul Smith |
| 112-0507544-8/1/1 | 23-Aug-2011 | 85MHK | 3008456389 | Kitazato Medical Co Ltd |
| 112-0507544-8/2/1 | 23-Aug-2011 | 85MQF | 3008456389 | Kitazato Medical Co Ltd |
| 112-0093283-3/2/1 | 24-Aug-2011 | 78GCQ | 3007222774 | Olympus Corporatio |
| 112-0093283-3/1/1 | 24-Aug-2011 | 78GCQ | 3007222774 | Olympus Corporatio |
| 112-3367197-8/1/1 | 24-Aug-2011 | 66YIS99 | 3007891910 | Eisai Co Ltd |
| 112-3367197-8/2/1 | 24-Aug-2011 | 66YIS99 | 3007891910 | Eisai Co Ltd |
| D03-0221863-7/2/1/A | 25-Aug-2011 | 86HME | 3009028238 | Shin Nipon |
| D03-0221863-7/2/1/B | 25-Aug-2011 | 86HME | 3008264384 | Topcon Service Co., Ltd |
| D03-0221863-7/3/1/E | 25-Aug-2011 | 86HME | 3009028238 | Shin Nipon |
| D03-0221863-7/3/1/F | 25-Aug-2011 | 86HME | 3008264384 | Topcon Service Co., Ltd |
| D03-0221863-7/6/1/A | 25-Aug-2011 | 86HJO | 3009028238 | Shin Nipon |
| D03-0221863-7/6/1/B | 25-Aug-2011 | 86HJO | 3008264384 | Topcon Service Co., Ltd |
| D03-0221863-7/9/1 | 25-Aug-2011 | 86HOS | 3008264384 | Topcon Service Co., Ltd |
| D03-0221863-7/11/1 | 25-Aug-2011 | 86HLM | 3002680900 | Tomey Corporation |
| D03-0221863-7/13/1 | 25-Aug-2011 | 86HKY | 3008264384 | Topcon Service Co., Ltd |
| D03-0221863-7/14/1/A | 25-Aug-2011 | 86HKN | 3009028237 | Nidek Co Ltd |
| D03-0221863-7/14/1/B | 25-Aug-2011 | 86HKN | 1000181430 | Canon Inc. |
| D03-0221863-7/14/1/C | 25-Aug-2011 | 86HKN | 3008264384 | Topcon Service Co., Ltd |
| D03-0221863-7/17/1/A | 25-Aug-2011 | 86HLM | 3008264384 | Topcon Service Co., Ltd |
| D03-0221863-7/17/1/B | 25-Aug-2011 | 86HLM | 1000181430 | Canon Inc. |
| 112-3365138-4/1/1 | 25-Aug-2011 | 80GCX | 3001595398 | FUJITA MEDICAL INSTRUMENTS CO., LTD |
| 004-6019962-3/2/1 | 29-Aug-2011 | 80FNK | 6829 | Paramount Bed Company Ltd. |
| 427-7322892-1/7/3 | 30-Aug-2011 | 25JGP21 | 3004250340 | SHIN SHIN MAEBASHI CO.,LTD |
| 112-3297464-7/1/1 | 31-Aug-2011 | 86NQE | 3003640598 | Nid Com |
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