Refusal Actions by FDA as Recorded in OASIS for Sri Lanka

   Manufacture Name
   City / Country or region                      District  Entry/Doc/Line/Suffix
   Product Code        Product Description
                          Date                             Reason
Pan Am Foods Ltd. Colombo 8 , LK 1234 LOS-DO DX2-0070814-8/4/1 29YYE99 NESTAMALT ENERGY DRINK 03-APR-2008 NUTRIT LBL NEEDS FCE NO PROCESS Pan Am Foods Ltd. Colombo 8 , LK 1234 LOS-DO DX2-0070814-8/5/1 09CYT16 Full Cream Milk Powder 03-APR-2008 LIST INGRE MFR INSAN LACKS N/C NO ENGLISH NUTRIT LBL Pan Am Foods Ltd. Colombo 8 , LK 1234 LOS-DO DX2-0070814-8/6/1 09YYT99 Full Cream Milk Powder 03-APR-2008 LIST INGRE MFR INSAN LACKS N/C NO ENGLISH NUTRIT LBL Pan Am Foods Ltd. Colombo 8 , LK 1234 LOS-DO DX2-0070814-8/30/1 25YYE99 vegetable in bottles 03-APR-2008 NO PROCESS Pan Am Foods Ltd Colombo , LK LOS-DO HA9-0800009-4/62/2 25FCI99 Gotukola Theldala 03-APR-2008 TRANSFAT NUTRIT LBL NEEDS FCE NO PROCESS Link Natural Products Private Ltd Colombo , LK NOL-DO 112-1930695-1/1/1 54ACY99 857384898779 SUPPLEMENT 08-APR-2008 HEALTH C Link Natural Products Private Ltd Colombo , LK NOL-DO 112-1930695-1/1/2 54ACY99 857384898779 SUPPLEMENT 08-APR-2008 HEALTH C Link Natural Products Private Ltd Colombo , LK NOL-DO 112-1930695-1/1/3 54ACY99 857384898779 SUPPLEMENT 08-APR-2008 HEALTH C W. WOODWARD PAKISTAN LTD. KARACHI , PK LOS-DO WNS-0280151-3/17/2E 66VBL99 WOODWARD'S CELEBRATED "GRIPE WATER" 17-APR-2008 UNAPPROVED Hettigoda Industries(Pvt)Ltd Ratmalana , LK LOS-DO WNS-0280151-3/17/2D 66VBJ99 SIDDHALEPA 17-APR-2008 FALSE LABELING Hettigoda Industries(Pvt)Ltd Ratmalana , LK LOS-DO WNS-0280151-3/17/2C 66VBJ99 SIDDHALEPA 17-APR-2008 FALSE LABELING Pan Am Foods Ltd. Colombo 8 , LK 1234 LOS-DO WNS-0280151-3/17/2B 54EET99 Samahan 17-APR-2008 FALSE HEALTH C Pan Am Foods Ltd. Colombo 8 , LK 1234 LOS-DO WNS-0280151-3/16/7 37KCI99 TAMARINE PASTE 17-APR-2008 FILTHY Pan Am Foods Ltd. Colombo 8 , LK 1234 LOS-DO WNS-0280151-3/10/1 28EGT04 ROASTED CURRY POWDER 17-APR-2008 SALMONELLA Pan Am Foods Ltd. Colombo 8 , LK 1234 LOS-DO WNS-0280151-3/1/1 21SCI09 BREADFRUIT 17-APR-2008 NEEDS FCE NO PROCESS