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  5. Soterion Development, Inc. - 586355 - 05/04/2021
  1. Warning Letters

CLOSEOUT LETTER

Soterion Development, Inc. MARCS-CMS 586355 —

Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Gilberto Cedeno
Recipient Title
General Manager/Owner
Soterion Development, Inc.

Avenue 2nd West, David
Pedregal
Chiriqui
Panama

Issuing Office:
Center for Food Safety and Applied Nutrition

United States

Dear: Mr. Cedeno:

The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 586355, issued August 19, 2019. Based on our evaluation, it appears you have addressed the violations contained in the 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/
Robyn R. Jones
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition

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