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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 M50-0185025-9/1/1/B


Manufacturer FEI3008332785
Manufacturer NameJohnson Johnson  
Manufacturer Address line 192787 Issy Cdx 9  
Manufacturer Address line 2  
Manufacturer's CityIssy  
Manufacturer Province/State  
Manufacturer Country/AreaFrance  
Product Code53LD06  
Importer's Product DescriptionJOHNSON & JOHNSON SHOWER GEL 33.8OZ  
Refusal Date16-Feb-2012  
FDA DistrictNYK-DO  
Entry/doc/line/sfx M50-0185025-9/1/1/B
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
COLOR LBLG   602(e), 801(a)(3); MISBRANDING   The color additive appears to not have its packaging and labeling in conformity with such requirements as issued under section 721.  
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.  
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