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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 FS2-1120315-3/78/1

Manufacturer FEI3002806448
Manufacturer NameBeiersdorf AG  
Manufacturer Address line 1Unnastrasse 48  
Manufacturer Address line 2  
Manufacturer's CityHamburg  
Manufacturer Province/StateHamburg  
Manufacturer Country/AreaGermany  
Product Code53LC03  
Refusal Date23-Apr-2013  
FDA DistrictLOS-DO  
Entry/doc/line/sfx FS2-1120315-3/78/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
LIST INGRE   403(i)(2), 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(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food. [Misbranded, Section 403(i)(2)]."  
UNAPPROVED   505(a), 801(a)(3); UNAPPROVED NEW DRUG   The article appears to be a new drug without an approved new drug application.