Refusal Actions by FDA as Recorded in OASIS for Philippines
Manufacture Name
City / Country or region District Entry/Doc/Line/Suffix
Product Code Product Description
Date Reason
Total Nature's Great Value, Inc.
Silang Cavite, PH SEA-DO EE6-1237172-8/1/1
66VBL99 BIO ENZYME PLUS FRUIT JUICE
03-SEP-2008 UNAPPROVED
Santa Cruz Trading
Gen. Santos City , PH 9500 SAN-DO EBH-0061863-0/5/1
16AGD45 FRZN TUNA CUBES
03-SEP-2008 FILTHY
Edlou Enterprises
Manila PH-ILS, PH 1008 SAN-DO D11-0115257-1/3/1
16IGP59 SMOKED GUTTED ROUNDSCAD
09-SEP-2008 INSANITARY
Edlou Enterprises
Manila PH-ILS, PH 1008 SAN-DO D11-0115257-1/3/2
16IGP59 SMOKED ROUNDSCAD
09-SEP-2008 INSANITARY
SEACHAMP INTERNATIONAL EXPORT CORP.
PASAY CITY Ph-Nota, PH 1300 NYK-DO 334-3167725-2/1/1
16MGT09 FROZEN WHOLE CLEANED OCTOPUS,IQF/IWP,FULLY EVISCERATED - VAR
10-SEP-2008 SALMONELLA
Macropharma Corp.
Pasig PH-NOTA, PH 1605 LOS-DO E8L-1003987-8/1/1
54YCH99 Circulan Dietary Supplement
11-SEP-2008 UNAPPROVED
Macropharma Corp.
Pasig PH-NOTA, PH 1605 LOS-DO E8L-1003987-8/3/1A
54YCH99 Circulan Blister Packs (10 Capsules)
11-SEP-2008 UNAPPROVED
Macropharma Corp.
Pasig PH-NOTA, PH 1605 LOS-DO E8L-1003987-8/3/1B
54YCH99 Circulan Capsule Samples
11-SEP-2008 UNAPPROVED
Marigold Commodities Corp (plant)
San Juan (Metro Manila) , PH SWI-DO AX0-0022467-9/1/2
37JVY99 TAMARIND PASTE-REGULAR
12-SEP-2008 FILTHY
Marigold Commodities Corp (plant)
San Juan (Metro Manila) , PH SWI-DO AX0-0022467-9/1/3
37JVY99 TAMARIND PASTE-HOT
12-SEP-2008 FILTHY
A Tung Chingco / Permex Producer And Exporter Corp
Manila , PH SAN-DO EBH-0062121-2/11/1
16MEE03 SQUID
15-SEP-2008 NO PROCESS
Unilever Food Solutions
Paranaque , PH SAN-DO EBH-0062121-2/28/1
16YCI99 TUNA SPREAD
15-SEP-2008 NEEDS FCE
NO PROCESS
Nadel Food Products
Laguna PH-LAG, PH 4002 SEA-DO N16-1038355-9/16/3
21SCE10 SWEET JACKFRUIT
17-SEP-2008 NEEDS FCE
NO PROCESS
Nadel Food Products
Laguna PH-LAG, PH 4002 SEA-DO N16-1038355-9/16/4
21SCI24 PALM NUT - WHITE
17-SEP-2008 NEEDS FCE
NO PROCESS
Nadel Food Products
Laguna PH-LAG, PH 4002 SEA-DO N16-1038355-9/16/5
21SCI24 PALM NUT - RED
17-SEP-2008 NEEDS FCE
NO PROCESS
Nadel Food Products
Laguna PH-LAG, PH 4002 SEA-DO N16-1038355-9/16/6
21SCI24 PALM NUT -GREEN
17-SEP-2008 NEEDS FCE
NO PROCESS
Nadel Food Products
Laguna PH-LAG, PH 4002 SEA-DO N16-1038355-9/17/1
21UCE07 PINEAPPLE GEL (NATA DE PINA)
17-SEP-2008 NEEDS FCE
NO PROCESS
Nadel Food Products
Laguna PH-LAG, PH 4002 SEA-DO N16-1038355-9/17/2
23ECI05 COCONUT GEL
17-SEP-2008 NEEDS FCE
NO PROCESS
Nadel Food Products
Laguna PH-LAG, PH 4002 SEA-DO N16-1038355-9/17/3
23ECI05 COCONUT GEL-RED
17-SEP-2008 NEEDS FCE
NO PROCESS
Nadel Food Products
Laguna PH-LAG, PH 4002 SEA-DO N16-1038355-9/17/4
23ECI05 COCONUT GEL-GREEN
17-SEP-2008 NEEDS FCE
NO PROCESS
Nadel Food Products
Laguna PH-LAG, PH 4002 SEA-DO N16-1038355-9/27/1
23BCE05 COCONUT BALLS
17-SEP-2008 NEEDS FCE
NO PROCESS
Nadel Food Products
Laguna PH-LAG, PH 4002 SEA-DO N16-1038355-9/27/2
23BCE05 COCONUT STRING -PURE
17-SEP-2008 NEEDS FCE
NO PROCESS
Nadel Food Products
Laguna PH-LAG, PH 4002 SEA-DO N16-1038355-9/28/1
24ACE99 SWEET WHITE BEANS
17-SEP-2008 NEEDS FCE
NO PROCESS
Nadel Food Products
Laguna PH-LAG, PH 4002 SEA-DO N16-1038355-9/28/2
24ACE09 RED MUNG BEANS
17-SEP-2008 NEEDS FCE
NO PROCESS
CD Delicacies
Pampanga , PH LOS-DO 880-0069537-4/1/2
07BGT02 Cornic (Garlic Fried Corn)
17-SEP-2008 FILTHY
Frescomar Seahelm Corporation
Santos City , PH NYK-DO 241-9249775-8/1/1
16AVD45 FROZEN YELLOWFIN TUNA FILLETS
18-SEP-2008 FILTHY
Frescomar Seahelm Corporation
Santos City , PH NYK-DO 241-9249775-8/1/2
16AVD45 FROZEN YELLOWFIN TUNA FILLETS
18-SEP-2008 FILTHY
Gtech Dental Lab.
Marikina , PH SEA-DO 112-4481869-9/1/1
76E--IH 644395101345/DENTURE CERAMIC FUSED TO BA
19-SEP-2008 NOT LISTED
NO 510(K)