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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 M41-0783068-7/10/1/C


Manufacturer FEI3009164016
Manufacturer NameAINSA  
Manufacturer Address line 149 Av. Sur  
Manufacturer Address line 2Col. Harrison  
Manufacturer's CityPasaje 1 #16  
Manufacturer Province/StateSan Salvador  
Manufacturer Country/AreaEl Salvador  
Product Code53ED06  
FDA Product DescriptionSHAMPOOS (HAIR PREPARATIONS, NON-COLORING)  
Refusal Date21-Dec-2011  
FDA DistrictLOS-DO  
Entry/doc/line/sfx M41-0783068-7/10/1/C
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
NO ENGLISH   502(c); 801(a)(3) ;MISBRANDING   Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).  
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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