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  5. Leimax, Corp. - 633364 - 12/22/2023
  1. Warning Letters

CLOSEOUT LETTER

Leimax, Corp. MARCS-CMS 633364 —

Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Noe Ramirez
Recipient Title
Owner & President
Leimax, Corp.

179 Saw Mill River Rd #B
Yonkers, NY 10701
United States

Issuing Office:
Foreign Supplier Verification Program (FSVP)

United States

Secondary Issuing Offices

United States

Dear Mr. Noe Ramirez:

The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter CMS# 633364 dated October 7, 2022. Based on our evaluation, it appears that you have addressed the violation 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/
Anna Alexander
Director, Compliance Branch
Division of Northeast Imports-Compliance Branch
U.S. Food and Drug Administration

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