Refusal Actions by FDA as Recorded in OASIS for Guatemala
Manufacture Name
City / Country or region District Entry/Doc/Line/Suffix
Product Code Product Description
Date Reason
Contrasa
Guatemala , GT LOS-DO JK8-0114853-2/6/1
30NGT03 CREAM ESSENCE DRINK
05-MAY-2008 NEEDS FCE
Expofruve
Amatitlan , GT LOS-DO JK8-0114853-2/8/1
30AGT99 JAMAICA DRINK
05-MAY-2008 NEEDS FCE
Productos Alimenticios Centr B&B
Guatemala City , GT LOS-DO JK8-0114853-2/7/1
30AGT99 BLACKBERRY DRINK
05-MAY-2008 NO PROCESS
Hispanic Foods
Mixco , GT LOS-DO JK8-0114610-6/21/1
27AGT03 Sandwich spread
05-MAY-2008 NEEDS FCE
Tienda San Jorge
Huehuetenango GT-HU, GT None FLA-DO JN8-0014073-1/8/1
24HGN07 DRIED HOT PEPPER
13-MAY-2008 FILTHY
Conservas Y Congelados Yaestal S
La Escuadrilla , GT LOS-DO 024-7817705-4/2/1
21SCT05 PICKLED GREEN MANGO
16-MAY-2008 NEEDS FCE
NO PROCESS
Agroindustria Legumex,S.A.
Chimaltenango , GT PHI-DO 551-6666114-5/1/1
24AGD84 SUGAR SNAP PEAS;PLASTIC, SYNTH;RAW - FRESH, FROZEN, NATURAL
22-MAY-2008 PESTICIDE
Agroindustria Legumex,S.A.
Chimaltenango , GT PHI-DO 551-6663293-0/1/1
24AGD84 IQF FROZEN SUGAR SNAP PEAS
22-MAY-2008 PESTICIDE
Salvavidas Sa
Guatemala City , GT FLA-DO J50-0102706-7/5/1A
29BHT07 Pineapple Soda (67oz. Plastic Bottles)
22-MAY-2008 UNSAFE COL
NUTRIT LBL
Salvavidas Sa
Guatemala City , GT FLA-DO J50-0102706-7/5/1B
29BCT07 Pineapple Soda (12 oz. bottles)
22-MAY-2008 UNSAFE COL
NUTRIT LBL
Refrescos India Quiche, S. A.
Santa Cruz Del Quiche GT-QC, GT None FLA-DO J50-0102706-7/5/1C
29BCT07 Pineapple Soda (12 oz. bottles)
22-MAY-2008 UNSAFE COL
NUTRIT LBL
Coexport Sa
Guatemala , GT FLA-DO J50-0102706-7/5/3
29BHT02 ORANGE SODA
22-MAY-2008 UNSAFE COL
Vegetales Especiales S.A.
Guatemala , GT FLA-DO DM4-0225310-6/1/1
24AFC51 SNOW PEAS
23-MAY-2008 PESTICIDE
Cooperativa Integral Union de 4 Pinos R.L.
Santiago Gt-Sa, GT 03006 FLA-DO DM4-0203477-9/1/1
24AFC14 FRENCH BEANS
27-MAY-2008 PESTICIDE
Unipharm S.A
Guatemala , GT ATL-DO XXX-0153459-4/2/1
56ADZ10 Unicillina 4000000 UI Injectable
28-MAY-2008 UNAPPROVED
Laboratorios Vijosa, S.A. de C.V.
Unknown , SV ATL-DO XXX-0153459-4/2/2
62GDP18 Nordifenac (Diclofenac Sodium) Inj - 75 mg/3ml
28-MAY-2008 UNAPPROVED
Laboratorios Farmaceuticos Ghi,S.A.
Guatemala , GT ATL-DO XXX-0154083-1/1/1
54AGP90 Tres Nervon
28-MAY-2008 UNAPPROVED
FARNET
couldntell , GT ATL-DO XXX-0154083-1/1/2
54AGP90 Dexa-Brunevit
28-MAY-2008 UNAPPROVED
Laboratorios Lamfer, S.A.
Guatemala , GT ATL-DO XXX-0154083-1/1/3
54AGP90 Antineuritico Vitaminas neuritropas 25,000
28-MAY-2008 UNAPPROVED
Donovan Werke G.S.A International
Unknown , GT ATL-DO XXX-0154083-1/1/7
54BEL07 aminochelated iron
28-MAY-2008 UNAPPROVED
Laboratorios PIERSAN
Unknown , GT ATL-DO XXX-0154083-1/1/10
54AGP90 Neurokalina
28-MAY-2008 UNAPPROVED
Laboratorios PIERSAN
Unknown , GT ATL-DO XXX-0154083-1/1/4
61XCP08 ANTIHISTAMINICO
28-MAY-2008 UNAPPROVED
Laboratorios PIERSAN
Unknown , GT ATL-DO XXX-0154083-1/1/5
64LDP74 ARCO CORT IM
28-MAY-2008 UNAPPROVED
Bayer De Mexico Sa De Cv
Mexico Df FN, MX ATL-DO XXX-0154083-1/1/6
56BCA05 Binotal M.R. Ampicilina comprimidos 1 g
28-MAY-2008 UNAPPROVED
Laboratories Sante
Sante de Centroamerica , GT ATL-DO XXX-0154083-1/1/8
60LAR05 pwdered aspirin
28-MAY-2008 UNAPPROVED
Laboratories Sante
Sante de Centroamerica , GT ATL-DO XXX-0154083-1/1/9
60LAR05 pwdered aspirin
28-MAY-2008 UNAPPROVED
Caplin Laboratories Limited
Pondicherry , IN ATL-DO XXX-0154083-1/1/11
60SAC25 Ranitidina
28-MAY-2008 UNAPPROVED
Ranbaxy Pharmaceuticals Inc
New Delhi , IN 110019 ATL-DO XXX-0154083-1/1/12
60SAC25 HISTAC 300
28-MAY-2008 UNAPPROVED
Ranbaxy Pharmaceuticals Inc
New Delhi , IN 110019 ATL-DO XXX-0154083-1/1/13
60SAC25 HISTAC 300
28-MAY-2008 UNAPPROVED
Glaxo Smithkline Panama Sa
Panama , PA ATL-DO XXX-0154083-1/1/14
60LAC05 mejoral tablets
28-MAY-2008 UNAPPROVED
Glaxo Smithkline Panama Sa
Panama , PA ATL-DO XXX-0154083-1/1/15
60LAC01 acido acetilsalicalicilio polvo oral
28-MAY-2008 UNAPPROVED
Laboratorios Pheniel
Unknown , GT ATL-DO XXX-0154083-1/1/16
62GAF90 dillofenaco 100mg/cap
28-MAY-2008 UNAPPROVED
La boratorios Unido S.A.
San Lucas Sacatepequez , GT ATL-DO XXX-0154083-1/1/17
61TAC02 buclizine
28-MAY-2008 UNAPPROVED
Caplin Point Laboratories Ltd
Pondicherry , IN ATL-DO XXX-0154083-1/1/18
61WAF45 Fluconazol
28-MAY-2008 UNAPPROVED
Mavesa
Caracs , GT ATL-DO XXX-0154083-1/1/19
62GAC90 50 mg per pc
28-MAY-2008 UNAPPROVED
Schering Plough Sa De Cv
Xochimilco, Mexico , MX 106090 ATL-DO XXX-0154083-1/1/20
64LDP04 3 mg per ml
28-MAY-2008 UNAPPROVED
Bristol-Myers Squibb De Mexico
Mexico , MX 02300 ATL-DO XXX-0154083-1/1/21
56DCP30 KANAMYCIN
28-MAY-2008 UNAPPROVED
Drogueria Roland Louis
unknown , GT ATL-DO XXX-0154083-1/1/22
60LBC01 ANTIGRIP
28-MAY-2008 UNAPPROVED
Laboratorios Disfavil
Mixco , GT ATL-DO XXX-0154083-1/1/23
60QAJ56 ANESTICIO LOCAL
28-MAY-2008 UNAPPROVED
Donovan Werke G.S.A International
Unknown , GT ATL-DO XXX-0154083-1/1/24
63BCL02 para el alivio del broncoespasmo
28-MAY-2008 UNAPPROVED
Agroindustria Legumex,S.A.
Chimaltenango , GT FLA-DO 551-6662841-7/1/1
24AGD84 IQF FROZEN SUGAR SNAP PEAS
30-MAY-2008 PESTICIDE