Refusal Actions by FDA as Recorded in OASIS
Country of Origin Entry # DOC Line Suffix
Manufacture Name
City / Country or region District
Product Code Product Description
Date Reason
China 112-3105860-6 1 1
Budline Co Ltd
Shenzhen , CN SAN-DO
95L--22 864546358664 LASER
05-JUL-2008 FAILS STD
Thailand 112-3383042-4 1 1
Fabrinet Co Ltd
Lumlookka , TH 12130 SEA-DO
95L--22 935170781825 LASER UNITS
22-JUL-2008 NO REGISTR
Hong Kong SAR 112-1972378-3 1 1
Wayear International Limited
Hong Kong , HK SAN-DO
95L--22 955508056097 LASER POINTER
30-JUL-2008 NON STD
United States 112-3420198-9 1 1
Gymboree Corp
San Francisco, CA 94105-3000 SAN-DO
95L--22 850245885410 SCANER
30-JUL-2008 NO REGISTR
Indonesia TW2-0012599-9 1 1
Toshiba Consumer Products
Jawa Barat , ID 17550 FLA-DO
95L--31 COLOR TV SETS / FOR EXPORT ONLY/ FOR EXPORT ONLY / FOR EXPOR
02-JUL-2008 NON STD
Panama TW2-0012607-0 1 1
Panasonic Latin America S A
Colon , PA FLA-DO
95L--31 COMPACT AUDIO SYSTEMS
02-JUL-2008 NON STD
Panama TW2-0012613-8 1 1
Panasonic Latin America S A
Colon , PA FLA-DO
95L--31 AUDIO SYSTEMS / SCAK250PL-S / FOR EXPORT ONLY / EXPORT ONLY
14-JUL-2008 NON STD
China 406-0418273-9 1 1
Panasonic Logistics (Hong Kong)
Kowloon , HK FLA-DO
95R--DV CAR CD PLAYER W/RADIO - FOR EXPORT ONLY
14-JUL-2008 NON STD
China MT3-0104939-1 1 1
Union Source Co. Ltd.
Ningbo , CN FLA-DO
95R--ES Shock & Light Laser Pointer Pen
02-JUL-2008 NON STD
Malaysia 406-0418012-1 1 1
Panasonic Asia Ltd
Singapore , SG 199555 FLA-DO
95R--FV COMPACT AUDIO SYSTEM - FOR EXPORT ONLY
02-JUL-2008 NON STD
Malaysia 406-0418482-6 1 1
Panasonic Asia Ltd
Singapore , SG 199555 FLA-DO
95R--FV COMPACT AUDIO SYSTEM - FOR EXPORT ONLY
17-JUL-2008 NON STD
Japan 406-0418021-2 2 1
Matsushita Electric Industrial Co Ltd
Osaka Osaka, JP 542 FLA-DO
95R--FW DVD PLAYER - FOR EXPORT ONLY
02-JUL-2008 NON STD
China 406-0418630-0 1 1
Panasonic Logistics (Hong Kong)
Kowloon , HK FLA-DO
95R--FW DVD PLAYER - FOR EXPORT ONLY
14-JUL-2008 NON STD
China 112-3139299-7 1 1
Shenzhen Fangzhong
Shenzhen , CN SAN-DO
95R--FZ 862156563622 BARCODE SCANNER
18-JUL-2008 NO REGISTR
Sweden 554-3665112-3 19 1
Delaval International
Glinde , DE D21509 NOL-DO
95R--ZN VMS SENSOR LASER CAMERA MODEL OSL 103 1131 0130
28-JUL-2008 NON STD