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
Asa Pharmaceuticals Pty Ltd.
Taren Point , AU NSW2229 NOL-DO 112-8877879-0/1/1
80F--MI 859974430060 Injector Syringe
05-NOV-2007 NOT LISTED
NO 510(K)
Myofunctional Research Co.
Helensvale , AU NOL-DO 112-8857168-2/1/1
76M--QC 918753058932 PLASTIC MOUTHGUARDS
07-NOV-2007 NOT LISTED
NO 510(K)
Specific Freight
Tullamarine , AU NOL-DO 112-8799408-3/1/1
54AMB16 690145371416 JOINT SUPPORT TABLETS FOR CATS & DOGS
07-NOV-2007 LIST INGRE
NO ENGLISH
LABELING
Reach For Life
Knoxfield VIC, AU 3180 LOS-DO AEK-7724654-0/2/1
64JIY01 OXYSHOT SALINE SOLUTION (FORMAL ENTRY REQUESTED BY FDA)
27-NOV-2007 UNAPPROVED
Reach For Life
Knoxfield VIC, AU 3180 LOS-DO AEK-7724654-0/3/1
64JIY01 EQUINE OXYSHOT SALINE SOLUTION(FORMAL ENTRY REQUESTED BY FDA
27-NOV-2007 UNAPPROVED
Bzirk Marketing
Wantima , AU LOS-DO AEK-7682954-4/1/1
66VCJ99 SUNSCREEN SACHETS
27-NOV-2007 NOT LISTED
Synthetek Industries Pty Ltd
Highett , AU 3190 NOL-DO 112-8063897-6/1/1
66VCN99 946921511765 Synthelator Vasodilator, Synthellamin Appetite
29-NOV-2007 UNAPPROVED
Bomac Laboratories
Manukau City Auckland , NZ NOL-DO 112-8063664-0/1/1B
65FON04 946921511824 For Veterinary use Sterile Water For inlection
29-NOV-2007 NEW VET DR
Becton Dickinson Medical (Singapore)
Singapore , SG 639461 NOL-DO 112-8063664-0/1/1A
80F--MF 946921511824 Piston Syringe
29-NOV-2007 RX DEVICE
Synthetek Industries Pty Ltd
Highett , AU 3190 NOL-DO 112-8101343-5/1/1
66VDN99 946921512577 SYNTHERGINE LIVER PROTECTANT
29-NOV-2007 UNAPPROVED
Synthetek Industries Pty Ltd
Highett , AU 3190 NOL-DO 112-8063459-5/1/1
65FON04 946921511960 Veterinary use Sterile Water for injections &
29-NOV-2007 NEW VET DR
Synthetek Industries Pty Ltd
Highett , AU 3190 NOL-DO 112-8063314-2/1/1
65FON04 946921512030 Veterinary use Sterile Water for injections
29-NOV-2007 NEW VET DR
Sythetek Industries Pty Ltd
Highett , AU 3190 NOL-DO 112-8062714-4/1/1
54ACL05 946921512007 Synthelamin Appepitite Stimilator (B12)
29-NOV-2007 UNAPPROVED
Becton Dickinson Medical (Singapore)
Singapore , SG 639461 NOL-DO 112-8063177-3/1/1B
80F--MI 946921511879 PRECISION GLIDE NEEDLES
29-NOV-2007 RX DEVICE
Synthetek Industries Pty Ltd
Highett , AU 3190 NOL-DO 112-8063779-6/1/1
80F--MF 946921511846/PISTON SYRINGE
30-NOV-2007 RX DEVICE