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
Alimtype Pty Ltd
Montrose , AU LOS-DO AEK-7696029-9/1/1
79F--TY SURGERY MEASURING TOOLS
01-AUG-2007 NO 510(K)
Nutralife (Aust)
Burleigh AU-QL, AU 4220 NYK-DO U51-3006435-0/1/1
54GYT04 SHARK CARTILAGE POWER
08-AUG-2007 FILTHY
Nutralife (Aust)
Burleigh AU-QL, AU 4220 NYK-DO U51-3006445-9/1/1
54GYT04 SHARK CARTILAGE POWER
08-AUG-2007 FILTHY
Nutralife (Aust)
Burleigh AU-QL, AU 4220 NYK-DO U51-3006469-9/1/1
54GYT04 SHARK CARTILAGE POWER
08-AUG-2007 FILTHY
Nutralife (Aust)
Burleigh AU-QL, AU 4220 NYK-DO U51-3006502-7/1/1
54GYT04 SHARK CARTILAGE POWER
08-AUG-2007 FILTHY
Nutralife (Aust)
Burleigh AU-QL, AU 4220 NYK-DO U51-3006541-5/1/1
54GYT04 SHARK CARTILAGE POWER
08-AUG-2007 FILTHY
Zimmermann
Zetland , AU 2017 LOS-DO AEK-7699445-4/1/1
53GK-05 COSMETIC LIP GLOSS
10-AUG-2007 CSTIC LBLG
Skynet Express Pty Ltd
Mascot , AU LOS-DO AEK-7700077-2/1/1
76D--ZN DENTAL INSTRUMENTS (V RING OPERATORY PACK
14-AUG-2007 NO 510(K)
Merck Sharp & Dohme (Australia) Pty Ltd
Granville NSW, AU 2142 SAN-DO 112-7650100-6/3/1
62ODB28 849555407329 ENALAPRIL MALEATE
28-AUG-2007 NOT LISTED
UNAPPROVED
Merck Sharp & Dohme (Australia) Pty Ltd
Granville NSW, AU 2142 SAN-DO 112-7650100-6/3/2
62ODB28 849555407329 ENALAPRIL MALEATE
28-AUG-2007 NOT LISTED
UNAPPROVED
Pfizer Propriety Limited
West Ryde NSW, AU 2114 SAN-DO 112-7650100-6/8/1
62ODB14 849555407329 AMLODIPINE BESYLATE
28-AUG-2007 NOT LISTED
UNAPPROVED
Lmt Surgical
Brisbane , AU 4068 NOL-DO 112-7295185-8/1/1
87J--DS 940568772419 COMPRESSION SCREW
30-AUG-2007 NOT LISTED
Lmt Surgical
Brisbane , AU 4068 NOL-DO 112-7295185-8/2/1
76D--ZJ 940568772419/COMPRESSION DRIVER
30-AUG-2007 NOT LISTED