Sema International Inc.

Warning LetterClosed

Anan Barbarawi Sema International Inc. 1636 Gervais Ave Ste 15 Maplewood , MN 55109 United States shop@semavape.com sema.international@gmail.comFEI 3012829434Issued May 7, 2021Center for Tobacco Products

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3012829434.

Violations1

Issue DateMay 7, 2021

Product TypeTobacco

StatusClosed

Closeout LetterJun 7, 2022

Letter Details

Firm: Sema International Inc.
Location: Anan Barbarawi Sema International Inc. 1636 Gervais Ave Ste 15 Maplewood , MN 55109 United States shop@semavape.com sema.international@gmail.com
FEI Number: 3012829434
Country: United States
Issue Date: May 07, 2021
Issuing Office: Center for Tobacco Products
Product Type: Tobacco
Status: Closed
Closeout Letter: June 07, 2022

Summary

Sema International Inc. was warned for manufacturing and selling e-liquid tobacco products through its website without obtaining required premarket authorization orders from FDA. The company's e-liquid products, deemed tobacco products under the Family Smoking Prevention and Tobacco Control Act effective August 8, 2016, were found to violate Federal Food, Drug, and Cosmetic Act requirements by lacking the necessary marketing authorization for new tobacco products. The Center for Tobacco Products identified these violations following a review of the company's website (semavape.com) showing e-liquids offered for sale or distribution in the United States.

Sema International Inc. FDA Warning Letter, May 7, 2021