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  5. PT. Primo Indo Ikan - 581917 - 08/28/2019
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CLOSEOUT LETTER

PT. Primo Indo Ikan MARCS-CMS 581917 —

Delivery Method:
Electronic Mail
Product:
Food & Beverages

Recipient:
Recipient Name
Lucas J. Papierniak
Recipient Title
Director
PT. Primo Indo Ikan

888 Moaniala Street
Honolulu, HI 96821-2548
United States

lucasp@primoindoikan.com
Issuing Office:
Center for Food Safety and Applied Nutrition

5001 Campus Drive
College Park, MD 20740
United States


Dear Mr. Papierniak:

The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter # 581917, issued May 30, 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/
Maria G. Corpuz, Team Leader
Food Adulteration and Assessment Branch
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition