Refusal Actions by FDA as Recorded in OASIS for Pakistan
Manufacture Name
City / Country or region District Entry/Doc/Line/Suffix
Product Code Product Description
Date Reason
Green Industrial Products
Saddar, Karachi , PK NYK-DO KM6-0034496-4/2/1
20BGT18 DRY BLACK MULBERRY
10-APR-2008 SALMONELLA
Nobby Medical Instruments
Sialkot , PK 51310 SEA-DO N25-0280038-7/1/1B
76E--MN Circlet off Angle Serrated Tip R-55A
10-APR-2008 DEVICEGMPS
Nobby Medical Instruments
Sialkot , PK 51310 SEA-DO N25-0280038-7/1/1D
76E--MN Off Angle Inst with Serrated Tip 7A Guyer
10-APR-2008 DEVICEGMPS
Andromeda Enterprises
Behram , PK CIN-DO 361-2601029-1/1/1
79G--EN SURGICAL FORCEPS
14-APR-2008 DE IMP GMP
Andromeda Enterprises
Behram , PK CIN-DO 361-2601030-9/1/1
79G--EN SURGICAL FORCEPS
14-APR-2008 DE IMP GMP
K Plus International
Sialkot , PK LOS-DO M52-0057022-9/1/1
79H--TD EXTRACTING FORCEPS IMPORTER 02087392005
16-APR-2008 DEVICEGMPS
K Plus International
Sialkot , PK LOS-DO M52-0057022-9/1/2
76E--MJ ROOT ELEVATORS
16-APR-2008 DEVICEGMPS
K Plus International
Sialkot , PK LOS-DO M52-0057022-9/1/3
87H--RR SCISSORS
16-APR-2008 DEVICEGMPS
K Plus International
Sialkot , PK LOS-DO M52-0057022-9/1/4
78F--HQ NEEDLE HOLDER
16-APR-2008 DEVICEGMPS
K Plus International
Sialkot , PK LOS-DO M52-0057022-9/1/5
77K--CP SYRINGE
16-APR-2008 DEVICEGMPS
K Plus International
Sialkot , PK LOS-DO M52-0057022-9/1/6
87H--XB PROBE
16-APR-2008 DEVICEGMPS
K Plus International
Sialkot , PK LOS-DO M52-0057022-9/1/7
76E--IG RETRACTOR
16-APR-2008 DEVICEGMPS
K Plus International
Sialkot , PK LOS-DO M52-0057022-9/1/8
79H--TF BRACEY CURETTE
16-APR-2008 DEVICEGMPS
K Plus International
Sialkot , PK LOS-DO M52-0057022-9/1/9
76E--MN SCALERS
16-APR-2008 DEVICEGMPS
K Plus International
Sialkot , PK LOS-DO M52-0057022-9/1/10
79E--MF WAX KNIFE
16-APR-2008 DEVICEGMPS
K Plus International
Sialkot , PK LOS-DO M52-0057022-9/1/11
79E--MF LAB KNIFE
16-APR-2008 DEVICEGMPS
K Plus International
Sialkot , PK LOS-DO M52-0057022-9/1/12
79G--AF MIXING SPATULA
16-APR-2008 DEVICEGMPS
K Plus International
Sialkot , PK LOS-DO M52-0057022-9/1/13
87K--TZ CALLIPER
16-APR-2008 DEVICEGMPS
K Plus International
Sialkot , PK LOS-DO M52-0057022-9/1/14
79H--TD FORCEP
16-APR-2008 DEVICEGMPS
K Plus International
Sialkot , PK LOS-DO M52-0057022-9/1/15
76E--IS CROWN REMOVER
16-APR-2008 DEVICEGMPS
K Plus International
Sialkot , PK LOS-DO M52-0057022-9/1/16
76E--IK WAX CARVER TIP
16-APR-2008 DEVICEGMPS
K Plus International
Sialkot , PK LOS-DO M52-0057022-9/1/17
76E--JB HANDLE FOR TIPS
16-APR-2008 DEVICEGMPS
K Plus International
Sialkot , PK LOS-DO M52-0057022-9/1/18
79H--TC PLIERS
16-APR-2008 DEVICEGMPS
K Plus International
Sialkot , PK LOS-DO M52-0057022-9/1/19
79H--TD MOSQUITO FORCEP
16-APR-2008 DEVICEGMPS
K Plus International
Sialkot , PK LOS-DO M52-0057022-9/1/20
76E--JB TWEEZER
16-APR-2008 DEVICEGMPS
K Plus International
Sialkot , PK LOS-DO M52-0057022-9/1/21
76E--KB EXPLORER
16-APR-2008 DEVICEGMPS
K Plus International
Sialkot , PK LOS-DO M52-0057022-9/1/22
76E--IY FILLING INSTRUMENT
16-APR-2008 DEVICEGMPS
K Plus International
Sialkot , PK LOS-DO M52-0057022-9/1/23
76E--KH AMALGAM CARVER
16-APR-2008 DEVICEGMPS
K Plus International
Sialkot , PK LOS-DO M52-0057022-9/1/24
78F--HQ HOLDER
16-APR-2008 DEVICEGMPS
K Plus International
Sialkot , PK LOS-DO M52-0057022-9/1/25
79F--SM TRAY FOR STERLIZATION
16-APR-2008 DEVICEGMPS
K Plus International
Sialkot , PK LOS-DO M52-0057022-9/1/26
76E--KI AMALGAM CARRIER
16-APR-2008 DEVICEGMPS
K Plus International
Sialkot , PK LOS-DO M52-0057022-9/1/27
87H--TX BONE RONGEOURS
16-APR-2008 DEVICEGMPS
K Plus International
Sialkot , PK LOS-DO M52-0057022-9/1/28
76E--IK WAX CARVER
16-APR-2008 DEVICEGMPS
Nawaz, Ahmed Dr.
Jauharabad , PK NYK-DO DO7-8716687-8/1/1
66SDH27 NIFEDIPINE CAPSULES FOR RAYNAUD'S PHENOMENON
16-APR-2008 UNAPPROVED
A.L.M. Surgicare
Sialkot, Punjab , PK 51310 CHI-DO 396-0151570-1/1/1
79H--TD FORCEPS
21-APR-2008 STAINSTEEL
A.L.M. Surgicare
Sialkot, Punjab , PK 51310 CHI-DO 396-0151570-1/1/2
76E--MH RONGUERS
21-APR-2008 NOT LISTED
STAINSTEEL
A.L.M. Surgicare
Sialkot, Punjab , PK 51310 CHI-DO 396-0151570-1/1/3
78F--HQ NEEDLE HOLDER
21-APR-2008 STAINSTEEL
A.L.M. Surgicare
Sialkot, Punjab , PK 51310 CHI-DO 396-0151570-1/1/4
87H--RR SCISSORS
21-APR-2008 STAINSTEEL
A.L.M. Surgicare
Sialkot, Punjab , PK 51310 CHI-DO 396-0151570-1/1/5
76E--IB SYRINGE
21-APR-2008 NOT LISTED
STAINSTEEL
A.L.M. Surgicare
Sialkot, Punjab , PK 51310 CHI-DO 396-0151570-1/1/6
79H--TE ELEVATOR
21-APR-2008 STAINSTEEL
A.L.M. Surgicare
Sialkot, Punjab , PK 51310 CHI-DO 396-0151570-1/1/7
79H--TD FORCEP
21-APR-2008 STAINSTEEL
A.L.M. Surgicare
Sialkot, Punjab , PK 51310 CHI-DO 396-0151570-1/1/8
79H--TD FORCEP
21-APR-2008 NOT LISTED
STAINSTEEL
Shan Foods Industries
Karachi , PK 74900 NYK-DO BGK-0025328-7/41/1
28EFT99 SPICE MIX
23-APR-2008 SALMONELLA
English Biscuit Manufacturers (pvt) Ltd
Karachi Pk-Sd, PK 74900 NYK-DO BGK-0025328-7/33/1
03MHT99 COOKIES
23-APR-2008 LACKS N/C
TRANSFAT
English Biscuit Manufacturers (pvt) Ltd
Karachi Pk-Sd, PK 74900 NYK-DO BGK-0025328-7/34/1
03MHT99 COOKIES
23-APR-2008 LACKS N/C
TRANSFAT
English Biscuit Manufacturers (pvt) Ltd
Karachi Pk-Sd, PK 74900 NYK-DO BGK-0025328-7/35/1
03MHT99 COOKIES
23-APR-2008 LACKS N/C
TRANSFAT
English Biscuit Manufacturers (pvt) Ltd
Karachi Pk-Sd, PK 74900 NYK-DO BGK-0025328-7/36/1
03MHT99 COOKIES
23-APR-2008 LACKS N/C
TRANSFAT
Zona Industries
Sialkot, Punjab , PK 51310 NYK-DO AEK-9102833-8/1/1
76J--EX DENTAL PLIERS
29-APR-2008 STAINSTEEL