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  5. PT. SIG ASIA - 592584 - 12/17/2019
  1. Warning Letters

CLOSEOUT LETTER

PT. SIG ASIA MARCS-CMS 592584 —

Product:
Food & Beverages
Seafood/Seafood Product
Recipient:
Recipient Name
Shaun Tan
Recipient Title
Chairwoman
PT. SIG ASIA

Jl. Lumba-Lumba Lingkungan IV, RT. 01, RW. 04
Kel. Girian Bawah, Kec. Girian
Bitung
Sulawesi Utara 95542
Indonesia

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

5001 Campus Drive
College Park, MD 20740
United States

Dear Ms. Tan:

The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #592584, issued October 28, 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/
Mildred P. Benjamin
Branch Chief
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition

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