Refusal Actions by FDA as Recorded in OASIS for Australia
Manufacture Name
City / Country or region District Entry/Doc/Line/Suffix
Product Code Product Description
Date Reason
Sythetek Industries Pty Ltd
Highett , AU 3190 NOL-DO 112-8063112-0/1/1
80F--MF 946921511880/PISTON SYRINGE
03-DEC-2007 NOT LISTED
NO 510(K)
Becton Dickinson Medical (Singapore)
Singapore , SG 639461 NOL-DO 112-8063177-3/1/1A
80F--MF 946921511879 PISTON SYRINGES
03-DEC-2007 NOT LISTED
NO 510(K)
Schumacher Pharmaceuticals
Melbourne , AU LOS-DO AEK-7684855-1/1/1
66VCL99 EXTRACT
03-DEC-2007 NOT LISTED
UNAPPROVED
Synthetek Industries Pty Ltd
Highett , AU 3190 NOL-DO 112-8101243-7/1/1
80F--MF 946921512566/PISTON SYRINGE
05-DEC-2007 NOT LISTED
NO 510(K)
Synthetek Industries Pty Ltd
Highett , AU 3190 NOL-DO 112-8101168-6/1/1
80F--MF 946921512533/PISTON SYRINGE
05-DEC-2007 NOT LISTED
NO 510(K)
Synthetek Industries Pty Ltd
Highett , AU 3190 NOL-DO 112-8100974-8/1/1
80F--MF 946921512511/PISTON SYRINGE
05-DEC-2007 NOT LISTED
NO 510(K)
Synthetek Industries Pty Ltd
Highett , AU 3190 NOL-DO 112-8100879-9/1/1
80F--MF 946921512268/PISTON SYRINGE
05-DEC-2007 NOT LISTED
NO 510(K)
Becton Dickinson Medical (Singapore)
Singapore , SG 639461 NOL-DO 112-8077544-8/1/1
80F--MF 946921512095 PISTON SYRINGES AND NEEDLES
05-DEC-2007 NOT LISTED
NO 510(K)
Synthetek Industries Pty Ltd
Highett , AU 3190 NOL-DO 112-8077461-5/1/1
80F--MF 946921512029/PISTON SYRINGE
05-DEC-2007 NOT LISTED
NO 510(K)
Synthetek Industries Pty Ltd
Highett , AU 3190 NOL-DO 112-8063870-3/1/1
80F--MF 946921511868/PISTON SYRINGE
05-DEC-2007 NOT LISTED
NO 510(K)
Becton Dickinson Medical (Singapore)
Singapore , SG 639461 NOL-DO 112-8063844-8/1/1
80F--MF 946921511700 PISTON SYRINGES AND NEEDLES
05-DEC-2007 NOT LISTED
NO 510(K)
Synthetek Industries Pty Ltd
Highett , AU 3190 NOL-DO 112-8063730-9/1/1
80F--MF 946921511857/PISTON SYRINGE
05-DEC-2007 NOT LISTED
NO 510(K)
Synthetek Industries Pty Ltd
Highett , AU 3190 NOL-DO 112-8063696-2/1/1
80F--MF 946921511721/PISTON SYRINGE
05-DEC-2007 NOT LISTED
NO 510(K)
Becton Dickinson Medical (Singapore)
Singapore , SG 639461 NOL-DO 112-8063624-4/1/1
80F--MF 946921511798 PISTON SYRINGES AND NEEDLES
05-DEC-2007 NOT LISTED
NO 510(K)
Synthetek Industries Pty Ltd
Highett , AU 3190 NOL-DO 112-8063422-3/1/1
80F--MF 946921511950/PISTON SYRINGE
05-DEC-2007 NOT LISTED
NO 510(K)
Synthetek Industries Pty Ltd
Highett , AU 3190 NOL-DO 112-8062614-6/1/1
66VCN99 946921512018 SYNTHEROL SYNTHELATOR SYNTHELAMIN
05-DEC-2007 UNAPPROVED
Charles Sturt University Winery
New South Wales , AU LOS-DO 332-0186935-2/2/7
12BFC02 CREAM CHEESE BIDGEE WITH LEMON MYRTLE
13-DEC-2007 POISONOUS
Charles Sturt University Winery
New South Wales , AU LOS-DO 332-0186935-2/2/8
12BFC02 CREAM CHEESE BIDGEE WITH TAS PEPPERBERRY IN 4 OZ PKG
13-DEC-2007 POISONOUS
Charles Sturt University Winery
New South Wales , AU LOS-DO 332-0186935-2/2/13
12BFC02 CREAM CHEESE BIDGEE WITH TAS PEPPERVERRY 2 X 3 KG WHEELS
13-DEC-2007 POISONOUS
Glaxo Australia Ply. Ltd.
Boronia Glaxo, AU NOL-DO 112-0513410-2/1/1
80L--DQ 859976889352/ASTHMA PUFFER
14-DEC-2007 NOT LISTED
Nelson & Robertson Exports Pty Ltd
Sydney , AU 2000 SAN-DO K80-0944529-8/1/1B
03YGT99 NESTLE SMARTIES
21-DEC-2007 UNSAFE COL
LIST INGRE
YELLOW #5
Nelson & Robertson Exports Pty Ltd
Sydney , AU 2000 SAN-DO K80-0944529-8/1/7
03HGT99 ARNOTTS CHOCOLATE TIM TAM DOUBLE CHOCOLATE & RASPBERRY
21-DEC-2007 UNSAFE COL
LIST INGRE
NUTRIT LBL
Nelson & Robertson Exports Pty Ltd
Sydney , AU 2000 SAN-DO K80-0944529-8/7/5
33EGT05 NESTLE MUSK LIFESAVERS
21-DEC-2007 UNSAFE COL
NUTRIT LBL
Nelson & Robertson Exports Pty Ltd
Sydney , AU 2000 SAN-DO K80-0944529-8/2/1
37KCT99 KRAFT VEGEMITE (YEAST SPREAD)
21-DEC-2007 LIST INGRE
NUTRIT LBL