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U.S. Department of Health and Human Services

Import Refusal Report

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Refusal Details as Recorded in OASIS by FDA

for Refusal 113-2657590-6/22/1


Manufacturer FEI3004562973
Manufacturer NameMalher S.A.  
Manufacturer Address line 1Km. 50.2 Carretera Interamericana  
Manufacturer Address line 2  
Manufacturer's CityEl Tejar  
Manufacturer Province/StateChimaltenango  
Manufacturer Country/AreaGuatemala  
Product Code24FEF08  
FDA Product DescriptionPEPPER, HOT, N.E.C. (FRUIT USED AS VEGETABLE)  
Refusal Date14-Jan-2005  
FDA DistrictSWI-DO  
Entry/doc/line/sfx 113-2657590-6/22/1
FDA Sample AnalysisYes  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
NO ENGLISH   403(f), 801(a)(3); MISBRANDING   The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)) [Misbranded, Section 403 (f)].  
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