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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 429-0777577-1/2/1

Manufacturer FEI3008418130
Manufacturer NameMustafa Enterprises  
Manufacturer Address line 1MR 5/88, Thanai Lane, Jodia Bazar  
Manufacturer Address line 2  
Manufacturer's CityKarachi  
Manufacturer Province/StatePK-SD  
Manufacturer Country/AreaPakistan  
Product Code53LD06  
Refusal Date23-Jul-2012  
FDA DistrictSEA-DO  
Entry/doc/line/sfx 429-0777577-1/2/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
DIETARYLBL   403(s)(2)(B), 801(a)(3), misbranded   The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term ?dietary supplement,? which term may be modified with the name of such an ingredient. [Misbranding, Section 403(s)(2)(B)].  
LABELING   Section 4(a); 801(a)(3) Misbranding   The article appears in violation of FPLA because of its placement, form and/or contents statement.  
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).  
NUTRIT LBL   403(q); 801(a)(3); Misbranding   The article appears to be misbranded in that the label or labeling fails to bear the required nutrition information.  
UNAPPROVED   505(a), 801(a)(3); UNAPPROVED NEW DRUG   The article appears to be a new drug without an approved new drug application.