Refusal Actions by FDA as Recorded in OASIS for Japan
Manufacture Name
City / Country or region District Entry/Doc/Line/Suffix
Product Code Product Description
Date Reason
Tomoguchi
Kitakyushu-shi JP-40, JP 800-0245 SEA-DO ANP-0008950-9/6/1
02DGE99 RETORT POUCH RICE
06-FEB-2008 NEEDS FCE
NO PROCESS
Sankohen Shoten Oroshibu
Tokyo , JP 116 0009 SEA-DO ANP-0008950-9/29/1
30PCE03 GREEN TEA BOTTLE
06-FEB-2008 NEEDS FCE
NO PROCESS
K. K. ASHIKAGA HONTEN
KESENNUMA JP-04, JP 988-0031 LOS-DO 082-0299861-6/1/1
16AGT51 FRZ RAW SKIN-ON BONELESS BELLY OFF MAHI MAHI FILLETS SZ.3/4,
06-FEB-2008 FILTHY
Sabu Suisan Co Ltd
Oita , JP SEA-DO 112-0677907-9/7/1
16AFH33 FROZEN DRIED WHOLE SARDINES (FUKU FUKU IWASHI)
07-FEB-2008 MFR INSAN
NISHIKAWA CO.,LTD
SAIKI-GUN JP-34, JP 738-0514 ATL-DO ATK-4006733-3/10/1
16AGH33 FROZEN BOILED ANCHOVY
11-FEB-2008 INSANITARY
Panasonic
Osaka , JP FLA-DO 110-0875449-6/1/1
94R--BH PROJECTOR, TV RECEIVERS & PRODUCTS;;
15-FEB-2008 NO REGISTR
Kyowa Shokuhin Co Ltd
Shida Gun , JP NWE-DO 610-5115770-1/1/1
16XGD33 IQF JAPANESE SEA SCALLOPS
20-FEB-2008 NO ENGLISH
SALMONELLA
Daiso Industries Co., Ltd.
Higashihiroshima , JP 739-0008 SEA-DO ANP-0009137-2/5/1
80F--MP FOOTSORE PREVENTING PADS
25-FEB-2008 NOT LISTED
DIRECTIONS
NO ENGLISH
Daiso Industries Co., Ltd.
Higashihiroshima , JP 739-0008 SEA-DO ANP-0009137-2/22/1B
63RKY06 Toothpaste with Flouride
25-FEB-2008 DIRECTIONS
LACKS FIRM
UNAPPROVED
Daiso Industries Co., Ltd.
Higashihiroshima , JP 739-0008 SEA-DO ANP-0009137-2/148/1B
79L--RR FIRST AID KIT Invoice Line 117
25-FEB-2008 NOT LISTED
Daiso Industries Co., Ltd.
Higashihiroshima , JP 739-0008 SEA-DO ANP-0009149-7/3/1
80K--GX ADHESIVE PLASTERS
25-FEB-2008 NOT LISTED
DIRECTIONS
NO ENGLISH
Daiso Industries Co., Ltd.
Higashihiroshima , JP 739-0008 SEA-DO ANP-0009149-7/3/2
80K--GX FABRIC ADHESIVE PLASTER
25-FEB-2008 NOT LISTED
DIRECTIONS
NO ENGLISH
Daiso Industries Co., Ltd.
Higashihiroshima , JP 739-0008 SEA-DO ANP-0009149-7/3/3
80K--GX TRANSPARENT FIRST AID PLASTER
25-FEB-2008 NOT LISTED
Daiso Industries Co., Ltd.
Higashihiroshima , JP 739-0008 SEA-DO ANP-0009149-7/3/4
80K--GX MENDING PAD M
25-FEB-2008 NOT LISTED
Daiso Industries Co., Ltd.
Higashihiroshima , JP 739-0008 SEA-DO ANP-0009149-7/3/5
80K--GX WATERPROOF FILM
25-FEB-2008 NOT LISTED
Daiso Industries Co., Ltd.
Higashihiroshima , JP 739-0008 SEA-DO ANP-0009149-7/4/1
80K--GX WATERPROOF ADHESIVEBANDAGE
25-FEB-2008 NOT LISTED
DIRECTIONS
NO ENGLISH
Daiso Industries Co., Ltd.
Higashihiroshima , JP 739-0008 SEA-DO ANP-0009149-7/111/1
78E--YQ ETIQUETTE LINER
25-FEB-2008 NOT LISTED
Daiso Industries Co., Ltd.
Higashihiroshima , JP 739-0008 SEA-DO ANP-0009149-7/111/2
78E--YQ DRY NIGHT 4P
25-FEB-2008 NOT LISTED
Daiso Industries Co., Ltd.
Higashihiroshima , JP 739-0008 SEA-DO ANP-0009149-7/138/1
80F--OR Cutting Absorbent Cotton
25-FEB-2008 NOT LISTED
DIRECTIONS
NO ENGLISH
Daiso Industries Co., Ltd.
Higashihiroshima , JP 739-0008 SEA-DO ANP-0009149-7/5/1
80L--DQ FAIN GLOVE
25-FEB-2008 NOT LISTED
DIRECTIONS
NO ENGLISH
Daiso Industries Co., Ltd.
Higashihiroshima , JP 739-0008 SEA-DO ANP-0009149-7/7/1
80L--DQ TAPE
25-FEB-2008 NOT LISTED
DIRECTIONS
NO ENGLISH
Kiseido Co
Tokyo , JP LOS-DO HE8-0089652-5/1/3
54YCE99 NUTRITIONAL SUPPLEMENT-SUPPON POWER GOLD, 50G, IN BOTTLE
26-FEB-2008 DIET INGRE
A.L.A. Corporation
Tokyo , JP SEA-DO 110-1596030-1/1/1
66VBR99 SEIGEN LACTOBACILLUS FERMENTED EXTRACTS DIETARY SUPPLEMENT
27-FEB-2008 UNAPPROVED