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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 G08-0027818-9/6/1


Manufacturer FEI3009091770
Manufacturer NameHassan Al Ajmi Trading Co  
Manufacturer Address line 1City Bay Business Center N221  
Manufacturer Address line 2  
Manufacturer's CityAbu Hail  
Manufacturer Province/State  
Manufacturer Country/AreaUnited Arab Emirates  
Product Code53JC99  
FDA Product DescriptionOTHER PERSONAL CLEANLINESS PRODUCTS (NOT ANTIPERSPIRANT), N.E.C.  
Refusal Date24-Oct-2011  
FDA DistrictMIN-DO  
Entry/doc/line/sfx G08-0027818-9/6/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
LACKS FIRM   502(b)(1), 801(a)(3); MISBRANDING   The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.  
LACKS N/C   403(e)(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(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act [Misbranded, Section 403 (e)(2)].  
UNAPPROVED   505(a), 801(a)(3); UNAPPROVED NEW DRUG   The article appears to be a new drug without an approved new drug application.  
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