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
Rdl Pharmaceutical Laboratory Inc
Davao City , PH SAN-DO AWL-0709024-7/36/9
66VDJ99 WHITENING CREAM WITH MOISTURIZER
01-APR-2008 NOT LISTED
DRUG NAME
UNAPPROVED
Sara Lee Philippines, Inc.
Manila , PH 1780 SAN-DO AWL-0709024-7/39/2A
60QBY61 Deodorant/ Antiperspirant: Fresh Bouquet
01-APR-2008 NOT LISTED
Sara Lee Philippines, Inc.
Manila , PH 1780 SAN-DO AWL-0709024-7/39/2B
60QBY61 Deodorant/ Antiperspirant: Morning Fresh
01-APR-2008 NOT LISTED
Sara Lee Philippines, Inc.
Manila , PH 1780 SAN-DO AWL-0709024-7/39/2C
60QBY61 Deodorant/ Antiperspirant- Milk
01-APR-2008 NOT LISTED
Magnolia Inc
Cavite City , PH SAN-DO EBH-0060993-6/19/1
09CYF05 MAGNOLIA CHOCOLITE
02-APR-2008 NO PROCESS
Pacific Isles International Trading Inc
Quzon City , PH CHI-DO AD3-0315682-3/4/1
16IGP59 SMOKED ROUND SCAD
07-APR-2008 MFR INSAN
FIRST CATCH ENTERPRISES
Quezon City , PH 1102 SAN-DO D11-0114380-2/3/1
16IGP59 FROZEN SMOKED ROUND SCAD
08-APR-2008 MFR INSAN
Pascual Laboratories, Inc.
Bulacan , PH SEA-DO 221-3102716-5/1/1
54FBE99 MULUNGGAY CAPSULES - DIETARY SUPPLEMENT
08-APR-2008 UNSAFE COL
LIST INGRE
Food Industries Inc
Metro Manila , PH SAN-DO 427-7302340-5/8/9
07BDT99 BBQ Cracker Nuts
09-APR-2008 UNSAFE COL
LIST INGRE
SEACHAMP INTERNATIONAL EXPORT CORP.
PASAY CITY Ph-Nota, PH 1300 LOS-DO WRI-0470710-1/1/1
16MGD09 FRZ WHOLE CLEANED OCTOPUS
09-APR-2008 FILTHY
Zetra BV
Unknown , PH NOL-DO 112-2025124-6/2/1E
66VBU99 963172497895 Block & White Papaya Whitening Soap
09-APR-2008 NOT LISTED
COL ADDED
N-RX INACT
INCONSPICU
UNAPPROVED
Food Industries Inc
Metro Manila , PH FLA-DO 413-2820395-9/6/8
23BET07 CRACKER NUT - HOT & SPICY
10-APR-2008 UNSAFE COL
Food Industries Inc
Metro Manila , PH FLA-DO 413-2820395-9/6/5
23BET07 CRACKER NUT - BARBEQUE
10-APR-2008 UNSAFE COL
Erma Industries, Inc.
Navotas, Metro Manila PH-NOTA, PH 1485 BLT-DO U10-1080184-7/2/1
22BGN05 BITTERMELON LEAVES
10-APR-2008 PESTICIDES
Marigold Commodities
Mandaluyong City , PH SWI-DO AX0-0022025-5/1/3
21TCI14 TAMARIND PASTE (BIGLAND SINIGAND) REGULAR
14-APR-2008 FILTHY
Marigold Commodities
Mandaluyong City , PH SWI-DO AX0-0022025-5/1/4
21TCI14 TAMARIND PASTE (BIGLAND SINIGAND) HOT
14-APR-2008 FILTHY
Marigold Commodities
Mandaluyong City , PH SWI-DO AX0-0022059-4/1/3
21TCI14 TAMARIND PASTE (BIGLANG SINIGANG) REGULAR
14-APR-2008 FILTHY
Marigold Commodities
Mandaluyong City , PH SWI-DO AX0-0022059-4/1/4
21TCI14 TAMARIND PASTE (BIGLANG SINIGANG) HOT
14-APR-2008 FILTHY
International Pharmaceutical Inc
Cebu City Cebu, PH SAN-DO J14-0060048-9/77/1
63HCL15 OIL
16-APR-2008 UNAPPROVED
Del Monte Philippines, Inc
Makati City , PH SAN-DO J14-0060048-9/105/1
21AYI01 FRUIT COCKTAIL
16-APR-2008 NEEDS FCE
NO PROCESS
Sancanco Canning Corporation
Valenzuela Metro Manila, PH SAN-DO J14-0060048-9/108/1
24AEE51 GREEN PEAS
16-APR-2008 NEEDS FCE
NO PROCESS
Alaska Milk Corporation
Makati City , PH SAN-DO J14-0060048-9/103/1
09CEE99 MILK
16-APR-2008 NEEDS FCE
NO PROCESS
Nestle Philippines Inc
Makati , PH 1200 SAN-DO J14-0060048-9/65/1
09CEE99 MILK & CREAM
16-APR-2008 LABELING
NUTRIT LBL
Sara Lee Philippines, Inc.
Manila , PH 1780 SAN-DO EBH-0061093-4/47/1
66VAL99 LOTION
17-APR-2008 NOT LISTED
UNAPPROVED
Sara Lee Philippines, Inc.
Manila , PH 1780 SAN-DO EBH-0061093-4/46/1C
66VDU99 Whitening Antiperspirant/Deodorant, Clean & Fresh
17-APR-2008 NOT LISTED
UNAPPROVED
Sara Lee Philippines, Inc.
Manila , PH 1780 SAN-DO EBH-0061093-4/46/1B
66VDU99 Whitening Antiperspirant/Deodorant- Ultra Sport
17-APR-2008 NOT LISTED
UNAPPROVED
Sara Lee Philippines, Inc.
Manila , PH 1780 SAN-DO EBH-0061093-4/46/1A
66VDU99 Whitening Antiperspirant/Deodorant: Powder Fresh
17-APR-2008 NOT LISTED
UNAPPROVED
International Pharmaceutical Inc
Cebu City Cebu, PH SAN-DO EBH-0061093-4/45/1
62MDL01 Efficascent Oil (Methyl Salicylate, Camphor & Menthol)
17-APR-2008 NOT LISTED
Godiva Inc
Makati City , PH LOS-DO 916-1663952-1/10/1
66PBJ99 GREEN TEA SUNBLOCK CREAM
19-APR-2008 NOT LISTED
Godiva Inc
Makati City , PH LOS-DO 916-1663952-1/11/1
66PBJ99 GREEN TEA SUNBLOCK CREAM
19-APR-2008 NOT LISTED
Godiva Inc
Makati City , PH LOS-DO 916-1663952-1/33/1
66PBJ99 GREEN TEA SUNBLOCK CREAM
19-APR-2008 NOT LISTED
Godiva Inc
Makati City , PH LOS-DO 916-1663952-1/34/1
66PBJ99 GREEN TEA SUNBLOCK CREAM
19-APR-2008 NOT LISTED
Godiva Inc
Makati City , PH LOS-DO 916-1664284-8/13/1
66PBJ99 SUN PROTECTION CREAM
19-APR-2008 NOT LISTED
Godiva Inc
Makati City , PH LOS-DO 916-1664284-8/14/1
66PBJ99 SUN PROTECTION CREAM
19-APR-2008 NOT LISTED
Food Industries Inc
Metro Manila , PH SAN-DO EBH-0061093-4/19/1A
07BDT99 Nagaraya Cracker Nuts BBQ Flavor
22-APR-2008 UNSAFE COL
COLOR LBLG
Consumers Desire Trading Corp
Pasat City , PH LOS-DO AEK-7731225-0/1/1
66VDL99 COLLAGEN
22-APR-2008 UNSAFE SUB
UNAPPROVED
Ketsup Pinoy, Inc.
Catmon Malabon Mm , PH BLT-DO 253-1037103-1/4/3
21WCT14 Tamarind Juice
23-APR-2008 FILTHY
Guzent Inc.
Novaliches, Q.C. , PH CHI-DO 805-0069477-5/27/1
24AGE06 SWEET CHICKPEAS WHOLE BIG
25-APR-2008 NO PROCESS
New Jerusalem Enterprises
Quezon City , PH LOS-DO MD9-0026730-1/5/1
16ACT01 SALTED ANCHOVIES
30-APR-2008 FILTHY
BACTERIA