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
Bonecare Implants Sailkot , PK NOL-DO 112-8775506-2/1/1 87M--RY 857266775718 ORTHOPEDIC HANDPIECE HANDLE 01-NOV-2007 STAINSTEEL English Biscuit Manufacturers (pvt) Ltd Karachi Pk-Sd, PK 74900 BLT-DO BGK-0001319-4/1/1 03HGT08 BUTTER PUFF PACKET BISCUITS 06-NOV-2007 LIST INGRE TRANSFAT NUTRIT LBL YELLOW #5 English Biscuit Manufacturers (pvt) Ltd Karachi Pk-Sd, PK 74900 BLT-DO BGK-0001319-4/2/1 03AGT03 CLICK PACKET BISCUITS 06-NOV-2007 LIST INGRE TRANSFAT NUTRIT LBL English Biscuit Manufacturers (pvt) Ltd Karachi Pk-Sd, PK 74900 BLT-DO BGK-0001319-4/4/1 03AGT03 MARIE PACKET BISCUITS 06-NOV-2007 LIST INGRE TRANSFAT NUTRIT LBL English Biscuit Manufacturers (pvt) Ltd Karachi Pk-Sd, PK 74900 BLT-DO BGK-0001319-4/3/1 03AGT03 GLUCO PLUS PACKET BISCUITS 06-NOV-2007 LIST INGRE TRANSFAT NUTRIT LBL English Biscuit Manufacturers (pvt) Ltd Karachi Pk-Sd, PK 74900 BLT-DO BGK-0001319-4/5/1 03AGT03 PEANUT PIK PACKET BISCUITS 06-NOV-2007 LIST INGRE TRANSFAT NUTRIT LBL English Biscuit Manufacturers (pvt) Ltd Karachi Pk-Sd, PK 74900 BLT-DO BGK-0001319-4/6/1 03AGT03 PEANUT PISTA PACKET BISCUITS 06-NOV-2007 LIST INGRE TRANSFAT NUTRIT LBL English Biscuit Manufacturers (pvt) Ltd Karachi Pk-Sd, PK 74900 BLT-DO BGK-0001319-4/7/1 03AGT03 RIO VANILLA PACKET BISCUITS100 06-NOV-2007 LIST INGRE TRANSFAT NUTRIT LBL English Biscuit Manufacturers (pvt) Ltd Karachi Pk-Sd, PK 74900 BLT-DO BGK-0001319-4/8/1 03AGT03 SOOPER PACKET BISCUITS 06-NOV-2007 LIST INGRE TRANSFAT NUTRIT LBL English Biscuit Manufacturers (pvt) Ltd Karachi Pk-Sd, PK 74900 BLT-DO BGK-0001319-4/9/1 03AGT03 GLUCO PLUS HALF ROLL BISCUITS 06-NOV-2007 LIST INGRE TRANSFAT NUTRIT LBL English Biscuit Manufacturers (pvt) Ltd Karachi Pk-Sd, PK 74900 BLT-DO BGK-0001319-4/10/1 03AGT03 MARIE HALF ROLL BISCUITS 06-NOV-2007 LIST INGRE TRANSFAT NUTRIT LBL YELLOW #5 Shan Foods Industries Karachi , PK 74900 SEA-DO WUG-0140312-9/1/7 28FGT04 KOFTA CURRY MIX 08-NOV-2007 SALMONELLA Stone Instruments Company Sialkot, Punjab , PK 51310 NYK-DO AEK-7212943-6/1/1 79H--TD FORCEPS 09-NOV-2007 STAINSTEEL Stone Instruments Company Sialkot, Punjab , PK 51310 NYK-DO AEK-7212943-6/1/2 85K--OH CURETTE 09-NOV-2007 STAINSTEEL Stone Instruments Company Sialkot, Punjab , PK 51310 NYK-DO AEK-7212943-6/1/3 85K--OH SKIN PUNCH 09-NOV-2007 STAINSTEEL AHMED IMPORT EXPORT HOUSE Karachi , PK 75700 CHI-DO 300-4620058-7/17/1 23BGH05 DRIED COCONUT 09-NOV-2007 NUTRIT LBL AHMED IMPORT EXPORT HOUSE Karachi , PK 75700 CHI-DO 300-4620058-7/5/3 25NCE21 GARLIC (WHOLE) PICKLED IN OIL 09-NOV-2007 NUTRIT LBL Kzk Industrial & Commercial Co. Karachi , PK CHI-DO K74-0141656-8/38/1 53CK-02 EYE LINER (KAJAL) TRADITIONAL EYE-LINER(PEN 13-NOV-2007 COSM COLOR Jfu Industries Sialkot , PK NYK-DO AEK-7210878-6/1/1 79L--RW OPERATING SCIRRORS 13-NOV-2007 DV QUALITY Jfu Industries Sialkot , PK NYK-DO AEK-7210878-6/1/2 79H--TD DRESSING FORCEPS 13-NOV-2007 DEVICEGMPS Green Industrial Products Saddar, Karachi , PK NYK-DO KM6-0033897-4/3/1 21HGT01 ASHTAQ ROLL 15-NOV-2007 FILTHY Manner Products Sialkot , PK CHI-DO AD3-0310081-3/1/1 79H--TD SURGICAL FORCEPS 19-NOV-2007 STAINSTEEL Manner Products Sialkot , PK CHI-DO AD3-0310081-3/2/1 78F--HQ SURGICAL NEEDLE HOLDERS 19-NOV-2007 STAINSTEEL Medisporex Limited Sialkot , PK FLA-DO M21-0736559-7/1/1 76E--GN SURGICAL SCISSORS 28-NOV-2007 DE IMP GMP National Foods Limited Karachi , PK 75760 SEA-DO 113-4095476-4/35/1 37JCI99 IMLI CHUTNEY SAUCE 29-NOV-2007 FILTHY NO PROCESS National Foods Limited Karachi , PK 75760 SEA-DO 113-4095476-4/36/1 27YCI03 RAJ MANGO CH SAUCE 29-NOV-2007 PRESRV LBL NO PROCESS National Foods Limited Karachi , PK 75760 SEA-DO 113-4095476-4/38/1 27YCT03 RAJ IMLI CHUTNEY SAUCE 29-NOV-2007 FILTHY NO PROCESS National Foods Limited Karachi , PK 75760 SEA-DO 113-4095476-4/51/1 37KGT23 VINDALOO CURRY PST 29-NOV-2007 FILTHY NO PROCESS Yarsons Sialkot-51310 , PK CHI-DO DQ4-4829959-3/1/1 76E--MD HEMOSTAT, SURGICAL;; 30-NOV-2007 NOT LISTED DEVICEGMPS REGISTERED NO 510(K)