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  5. Comercial Mares de Chiloe - 587913 - 01/31/2020
  1. Warning Letters

CLOSEOUT LETTER

Comercial Mares de Chiloe MARCS-CMS 587913 —

Product:
Food & Beverages
Seafood/Seafood Product
Recipient:
Recipient Name
Ignacio Samacoitz
Comercial Mares de Chiloe

Cardonal Bajo 2, 7 Lote 1A
5500000 Puerto Montt
Los Lagos
Chile

Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)

5001 Campus Drive
College Park, MD 20740
United States

Dear Mr. Samacoitz:

The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #587913, 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, Team Lead
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition

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