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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 112-4145805-3/1/1

Manufacturer FEI3002735976
Manufacturer NamePeter Thomas Roth Labs, LLC  
Manufacturer Address line 1460 Park Ave Fl 16th  
Manufacturer Address line 2  
Manufacturer's CityNew York  
Manufacturer Province/StateNY  
Manufacturer Country/AreaUnited States  
Product Code53GH02  
Importer's Product Description496137846652 INSTANT MINERAL POWDER  
Refusal Date25-Nov-2011  
FDA DistrictNOL-DO  
Entry/doc/line/sfx 112-4145805-3/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
FALSE   403(a)(1), 801(a)(3); MISBRANDING   The labeling appears to be false and misleading in any particular.  
LACKS FIRM   403(e)(1), 801(a)(3); MISBRANDING   The food is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.  
NOT LISTED   502(o), 801(a)(3); MISBRANDING   It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).  
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