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
Industrias Rick'S, S.A.
Mixco , GT FLA-DO AM1-0150354-9/8/1A
07ADT02 Snack Chips
04-MAR-2008 NO ENGLISH
Industrias Rick'S, S.A.
Mixco , GT FLA-DO AM1-0150354-9/9/1
07ADT02 CHIPS: TORTILLA CORN CHIPS
04-MAR-2008 NO ENGLISH
Cooperativa Agricola Integral "Magdalena" R.L.
Magdalena Milpas Altas Sacatepequez, GT 0101 FLA-DO WV4-0010471-0/1/1
24AFC84 FRESH SUGAR PEAS ( 1800 BOXES)
06-MAR-2008 PESTICIDE
Export Imports San Rafael
Guatemala , GT FLA-DO AM1-0150354-9/8/1B
07BGT05 Popcorn Balls (6-pack)
10-MAR-2008 UNSAFE COL
LIST INGRE
Bellcas Exportando, S.A.
Guatemala City Sacatepequez, GT 03004 NYK-DO H67-1308419-1/1/1
24AFB14 FRESH FRENCH BEAN
12-MAR-2008 PESTICIDE
Drodijosa
unknown , GT ATL-DO XXX-0151423-2/1/1
54AEP05 Neuro Fosckrol-vit / Vitamin B12 ampules/ Injectables (Tonic
13-MAR-2008 UNAPPROVED
Laprin
Unknown , GT ATL-DO XXX-0151423-2/1/4
54ACC90 Neumonil Forte (Alivito MultipleY Eficaz) Tablets
13-MAR-2008 UNAPPROVED
Bayer S.A.
Unknown , GT ATL-DO XXX-0151423-2/1/6
60LDA01 Tabcin (Ninos Efervescente with Acetaminophen)
13-MAR-2008 PERSONALRX
Donovan Werke A.G.S.A. International
Villa Nueva , GT ATL-DO XXX-0151423-2/1/8
60LDA01 Gripetin caplets
13-MAR-2008 PERSONALRX
Bayer S.A.
Unknown , GT ATL-DO XXX-0151423-2/1/9
61WDL04 Canesten (1% Solucion Atomizodor) 30ml
13-MAR-2008 PERSONALRX
Drogueria Roland Louis
unknown , GT ATL-DO XXX-0151423-2/1/10
60LDA01 Antigrip Treatment (double dose- tabs & Injectable)
13-MAR-2008 PERSONALRX
Fortepsa
Unknown , GT ATL-DO XXX-0151423-2/1/11
60LDA01 Doloridol Analgesico Tabs
13-MAR-2008 PERSONALRX
Fortepsa
Unknown , GT ATL-DO XXX-0151423-2/1/12
60LDA01 Antigrip Tablets (Acetaminofen / Tramadol)
13-MAR-2008 PERSONALRX
Unipharma International, SA
Unknown , GT ATL-DO XXX-0151423-2/1/13
60LDA01 Unipulmin Basamico Topical Rub
13-MAR-2008 NO ENGLISH
Drogueria Roland Louis
unknown , GT ATL-DO XXX-0151423-2/1/14
60LDA01 AntiGrip (Jarabe) Liquid
13-MAR-2008 PERSONALRX
Ruipharma , S.A.
Guatemala City , GT ATL-DO XXX-0151423-2/1/15
55QP-58 Tosfranito Jarabe (30ml) solution
13-MAR-2008 PERSONALRX
Laboratorios Piersan
Unknown , GT ATL-DO XXX-0151441-4/1/3
65RDW06 Calcio Vitaminado Injections (5CC amps) In
13-MAR-2008 NOT LISTED
NO ENGLISH
Laboratorios Therfam
unknown , GT ATL-DO XXX-0151441-4/1/6
56EDF81 Tetraciclina HCL Capsules (500mg)
13-MAR-2008 NOT LISTED
Merck Centroamericana S.A.
unknown , GT ATL-DO XXX-0151441-4/1/9
54AGL05 Neurobion 25,000 Injection Vial (3ml)
13-MAR-2008 NO ENGLISH
LABELING
Sanofi-Aventis
Unknown , GT ATL-DO XXX-0151441-4/1/11
66VDY99 Neo-Melubrina (Metamizol Sodico) Tablets (500mg)
13-MAR-2008 NOT LISTED
NO ENGLISH
DANISCO DE CENTRO AMERICA, S.A.
Guatemala GT-GU, GT 01002 ATL-DO XXX-0151788-8/1/1O
54YCY99 tablets blend with milk microbial curdle, chloride
13-MAR-2008 NO ENGLISH
Laboratorios Quirarma, S.A.
unknown , GT ATL-DO XXX-0151902-5/1/1A
60SBA99 Soda Bicarbonate
13-MAR-2008 NO ENGLISH
Laboratorios Quirarma, S.A.
unknown , GT ATL-DO XXX-0151902-5/1/2
60IBA99 Bicarbonate of Soda
13-MAR-2008 NO ENGLISH
Laboratorios Quirarma, S.A.
unknown , GT ATL-DO XXX-0151902-5/1/3
66VJA99 Neo Melubrina
13-MAR-2008 DIRECTIONS
NO ENGLISH
UNKNOWN
UNKNOWN , GT ATL-DO XXX-0152364-7/2/1
66VDY99 Personal Baggage (3 bags) carried by passenger with Commeria
13-MAR-2008 UNAPPROVED
UNKNOWN
UNKNOWN , GT ATL-DO XXX-0152364-7/2/2
16AFH99 Personal Baggage (3 bags) carried by passenger with Commeria
13-MAR-2008 FILTHY
INSANITARY
Coexport Sa
Guatemala , GT FLA-DO J50-0100729-1/7/1
37JHT99 HOT SAUCE
19-MAR-2008 NEEDS FCE
NO PROCESS
Guatexport
Guatemala , GT FLA-DO ATG-1004416-8/7/1
25ECI99 CURTIDO IN GLASS JAR
20-MAR-2008 NO PROCESS
Intact Guatemala
Colinas De Monte Mariasur , GT FLA-DO BFV-0155449-2/1/1A
03AGT99 BREAD
21-MAR-2008 UNSAFE COL
FILTHY
LACKS FIRM
NUTRIT LBL
Intact Guatemala
Colinas De Monte Mariasur , GT FLA-DO BFV-0155449-2/1/1B
03AGT99 Kaiser Roll Breads
21-MAR-2008 UNSAFE COL
FILTHY
LACKS FIRM
NUTRIT LBL
Intact Guatemala
Colinas De Monte Mariasur , GT FLA-DO BFV-0155449-2/1/1C
03AGT99 Seed Covered Pretzel Breads
21-MAR-2008 UNSAFE COL
LACKS FIRM
NUTRIT LBL
Intact Guatemala
Colinas De Monte Mariasur , GT FLA-DO BFV-0155449-2/3/1
07ADT99 TORTRIX/SNACKS
21-MAR-2008 NO ENGLISH
Intact Guatemala
Colinas De Monte Mariasur , GT FLA-DO BFV-0155449-2/4/1
24BGT05 Toasted Aba Seeds
21-MAR-2008 LIST INGRE
LACKS N/C
NUTRIT LBL
Intact Guatemala
Colinas De Monte Mariasur , GT FLA-DO BFV-0155449-2/5/1
24HGH08 DRY HOT CHILI
21-MAR-2008 LACKS N/C
NUTRIT LBL
Intact Guatemala
Colinas De Monte Mariasur , GT FLA-DO BFV-0155449-2/6/1
24AAT07 Piloy Red Beans
21-MAR-2008 LACKS FIRM
LACKS N/C
NUTRIT LBL
Intact Guatemala
Colinas De Monte Mariasur , GT FLA-DO BFV-0155449-2/7/1
24BGH05 Dried Aba Seed
21-MAR-2008 LACKS FIRM
LACKS N/C
NUTRIT LBL
Malher Sucesores
Cuidad De Guatemala , GT FLA-DO F23-0518258-6/3/10
30AHT99 INSTANT SOFT DRINK MIX TAMARINDO FLAVORED
24-MAR-2008 FILTHY