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  5. YemenUSA Inc. - 615141 - 02/14/2023
  1. Warning Letters

CLOSEOUT LETTER

YemenUSA Inc. MARCS-CMS 615141 —

Product:
Food & Beverages
Recipient:
Recipient Name
Sami Alsulaimani
Recipient Title
Owner President
YemenUSA Inc.

8864 Greenfield Road
Detroit, MI 48228-2237
United States

Issuing Office:
Division of Northern Border Imports

United States

Dear Sami Alsulaimani:

The Food and Drug Administration has completed an evaluation of YemenUSA Inc’s corrective actions in response to our Warning Letter CMS# 615141 dated July 22, 2021. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.

This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.


Sincerely,
/S/
Sherea L. Dillon
Director of Compliance
Division of Northern Border Imports
Office of Regulatory Affairs
U.S. Food and Drug Administration

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