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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 D03-0228918-2/26/1/B

Manufacturer FEI3002652064
Manufacturer NameMann Schroder Gmbh  
Manufacturer Address line 114 Bahnhofsrabe  
Manufacturer Address line 2  
Manufacturer's CityBaden  
Manufacturer Province/State  
Manufacturer Country/AreaGermany  
Product Code53BD99  
Importer's Product DescriptionBATH PREPS  
Refusal Date23-Dec-2011  
FDA DistrictNYK-DO  
Entry/doc/line/sfx D03-0228918-2/26/1/B
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
COSM COLOR   601(e), 801(a)(3); ADULTERATION   The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).  
CSTIC LBLG   602(a) and/or (b), and/or (c), 801(a)(3); MISBRANDING   The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.  
LABELING   Section 4(a); 801(a)(3) Misbranding   The article appears in violation of FPLA because of its placement, form and/or contents statement.  
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