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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 G08-0027818-9/4/1

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 Code53ED01  
Refusal Date24-Oct-2011  
FDA DistrictMIN-DO  
Entry/doc/line/sfx G08-0027818-9/4/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
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).  
UNAPPROVED   505(a), 801(a)(3); UNAPPROVED NEW DRUG   The article appears to be a new drug without an approved new drug application.