Refusal Actions by FDA as Recorded in OASIS for Hong Kong SAR

   Manufacture Name
   City / Country or region                      District  Entry/Doc/Line/Suffix
   Product Code        Product Description
                          Date                             Reason
Als Orient Supplies Co. Ltd Kowloon Bay , HK 05000 SEA-DO 112-3736565-8/1/1 89I--MD 864252428249 FOOT PAD/USE UNDER THE FEET 05-AUG-2008 NOT LISTED REGISTERED NO 510(K) Als Orient Supplies Co. Ltd Kowloon Bay , HK 05000 SEA-DO 112-3738877-5/1/1 89I--MD 864252428227 FOOT PADS, USE BET SHOE & F 05-AUG-2008 NOT LISTED NO 510(K) Fung Shing Thai Industrial Co. Kowloon , HK SWI-DO 411-8164507-2/1/1 33LGH13 CANDY 06-AUG-2008 LACKS FIRM LACKS N/C LABELING Solid Company Limited Hong Kong , HK FLA-DO TW2-0012201-2/1/1 95L--31 AUDIO SYSTEMS / FOR EXPORT ONLY / FOR EXPORT ONLY 11-AUG-2008 NON STD Solid Company Limited Hong Kong , HK FLA-DO TW2-0012201-2/2/1 95L--31 AUDIO SYSTEMS / FOR EXPORT ONLY / FOR EXPORT ONLY 11-AUG-2008 NON STD Solid Company Limited Hong Kong , HK FLA-DO TW2-0012439-8/1/1 95L--31 MINI HI FI COMPONENTS / FOR EXPORT ONLY 11-AUG-2008 NON STD Jenny Beauty College Kowloonkowloon , HK 999999 NYK-DO UPS-1880358-3/1/1 53LC-99 MOLE REMOVAL CREAM 19-AUG-2008 NOT LISTED Companion Co. Hong Kong , HK NYK-DO BMY-3009443-9/10/1 21TGH18 FROZEN DRIED LONGAN PULP 21-AUG-2008 UNSAFE COL Zegna-Daidong Limited Kowloon , HK FLA-DO TW2-0012684-9/1/1 95L--31 AUDIO SYSTEMS / FOR EXPORT ONLY 25-AUG-2008 NON STD Zegna-Daidong Limited Kowloon , HK FLA-DO TW2-0012684-9/2/1 95L--31 AUDIO SYSTEMS 25-AUG-2008 NON STD Zegna-Daidong Limited Kowloon , HK FLA-DO TW2-0012684-9/3/1 95L--31 AUDIO SYSTEMS 25-AUG-2008 NON STD Zegna-Daidong Limited Kowloon , HK FLA-DO TW2-0012684-9/4/1 95L--31 AUDIO SYSTEMS 25-AUG-2008 NON STD Zegna-Daidong Limited Kowloon , HK FLA-DO TW2-0012684-9/5/1 95L--31 AUDOIO SYSTEMS 25-AUG-2008 NON STD Koon Chun Hing Kee Soy & Sauce Factory Au Tau Yuen Long N T, HK LOS-DO 880-0070080-2/1/1 37JET11 HOISIN SAUCE 26-AUG-2008 NEEDS FCE NO PROCESS Koon Chun Hing Kee Soy & Sauce Factory Au Tau Yuen Long N T, HK LOS-DO 880-0070080-2/2/1 37JET17 GOUND BEAN SAUCE 26-AUG-2008 NEEDS FCE NO PROCESS Koon Chun Hing Kee Soy & Sauce Factory Au Tau Yuen Long N T, HK LOS-DO 880-0070080-2/2/2 37JCT17 BEAN SAUCE 26-AUG-2008 NEEDS FCE NO PROCESS Koon Chun Hing Kee Soy & Sauce Factory Au Tau Yuen Long N T, HK LOS-DO 880-0070080-2/3/1A 27VCP02 SWEETENED BLACK VINEGAR 26-AUG-2008 NEEDS FCE NO PROCESS KOON CHUN HING KEE SOY & SAUCE FACTORY LIMITED N T HK-NA, HK NONE LOS-DO 880-0070080-2/3/1B 27VCP02 Fine Shrimp Sauce 26-AUG-2008 NEEDS FCE NO PROCESS Euroframes Ltd Kowloon , HK LOS-DO 113-4266014-6/5/1 86H--QY SUNGLASSES 27-AUG-2008 REGISTERED Euroframes Ltd Kowloon , HK LOS-DO 113-4266014-6/8/1 86H--QY SUNGLASSES 27-AUG-2008 REGISTERED Euroframes Ltd Kowloon , HK LOS-DO 113-4266014-6/11/1 86H--QY SUNGLASSES 27-AUG-2008 REGISTERED Euroframes Ltd Kowloon , HK LOS-DO 113-4266014-6/14/1 86H--QY SUNGLASSES 27-AUG-2008 REGISTERED Euroframes Ltd Kowloon , HK LOS-DO 113-4266014-6/17/1 86H--QY SUNGLASSES 27-AUG-2008 REGISTERED