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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 MH9-0553610-7/1/1

Manufacturer FEI3004444881
Manufacturer NameDistribuidora Antonio Pereira  
Manufacturer Address line 1Calle Ppal Del Cementerio # 1496  
Manufacturer Address line 2  
Manufacturer's CityPariata Edo. Vargas, Venezuela  
Manufacturer Province/State  
Manufacturer Country/AreaVenezuela  
Product Code34FFT07  
Importer's Product DescriptionCANDIES  
Refusal Date01-Dec-2006  
FDA DistrictFLA-DO  
Entry/doc/line/sfx MH9-0553610-7/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
NO ENGLISH   403(f), 801(a)(3); MISBRANDING   Required label or labeling appears to not be in English per 21 CFR 101.15(c).  
NUTRIT LBL   403(q); 801(a)(3); Misbranding   The article appears to be misbranded in that the label or labeling fails to bear the required nutrition information.  
UNSAFE COL   402(c), 801(a)(3); ADULTERATION   The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).