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
SA TRADING COMPANY
KARACHI PK-SD, PK 75300 NYK-DO KM6-0037117-3/12/1
54FCT99 HERBAL SYRUP-GHUTTI
01-JUL-2008 UNAPPROVED
SA TRADING COMPANY
KARACHI PK-SD, PK 75300 NYK-DO KM6-0037117-3/13/1
53IG-01 MISWAK DENTIFRICES
01-JUL-2008 NOT LISTED
UNAPPROVED
SA TRADING COMPANY
KARACHI PK-SD, PK 75300 NYK-DO KM6-0037117-3/13/2
53IG-01 REVAND DENTIFRICES
01-JUL-2008 NOT LISTED
UNAPPROVED
SA TRADING COMPANY
KARACHI PK-SD, PK 75300 NYK-DO KM6-0037117-3/14/1
33EGT06 HERBAL TABLET-CARMINA
01-JUL-2008 UNAPPROVED
Zona Industries
Sialkot, Punjab , PK 51310 CIN-DO AEK-9496249-1/1/1
87K--TZ BRACKET POSITIONING GAUGE(CALIPER)
02-JUL-2008 DEVICEGMPS
Zona Industries
Sialkot, Punjab , PK 51310 CIN-DO AEK-9496249-1/2/1
76E--MN DENTAL SCALERS
02-JUL-2008 DEVICEGMPS
Mitchell'S Fruit Farms Limited
Lahore , PK CHI-DO E94-1055164-8/2/1
20RCN01 GOLDEN APPLE JAM
08-JUL-2008 UNSAFE COL
LACKS N/C
Quality Concept (Pvt) Ltd.
Sialkot , PK 1234 SWI-DO BJV-0210581-6/8/49
79L--RP STR IRIS SCISSOR, STRAIGHT, 4 5 #SSI-0001
09-JUL-2008 DE IMP GMP
Hilbro Instruments (Pvt), Ltd.
Sialkot , PK 51310 NYK-DO H77-0110304-3/1/1
73C--CW entry consists of 50 hollow/50 solid tube handles and 690 bl
10-JUL-2008 DEVICEGMPS
Z-Dehtamen
Sialkot , PK NYK-DO AEK-9107585-9/1/1
76E--JY MEDICAL PLIERS
28-JUL-2008 STAINSTEEL
National Foods Limited
Karachi , PK 75760 BLT-DO BMT-0023079-4/3/1
28BGH15 CORRIANDER
28-JUL-2008 SALMONELLA
National Foods Limited
Karachi , PK 75760 BLT-DO BMT-0023079-4/4/1
28BGH15 CORRIANDER
28-JUL-2008 SALMONELLA
National Foods Limited
Karachi , PK 75760 BLT-DO BMT-0023079-4/30/1
27YGT02 GREEN CHILI SAUCE
28-JUL-2008 NO PROCESS
Shan Foods Industries
Karachi , PK 74900 SEA-DO MK8-0384309-5/1/1A
28FHT99 Kofta Curry Mix
29-JUL-2008 SALMONELLA
Shan Foods Industries
Karachi , PK 74900 SEA-DO MK8-0384309-5/1/1E
28FHT99 Sp Kheer Mix
29-JUL-2008 SALMONELLA
Shan Foods Industries
Karachi , PK 74900 SEA-DO MK8-0384309-5/3/1
28BHT15 CORIANDER, GROUND, CRACKED (SPICE);NONFLEX PLASTIC;PACKAGED
29-JUL-2008 SALMONELLA
Shezan International Limited
Lahore , PK SWI-DO KM6-0107233-3/3/5
37JCT99 SOYA SAUCE
30-JUL-2008 NEEDS FCE
NO PROCESS