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  5. Pulmuone Foods USA, Inc. - 416366 - 09/30/2019
  1. Warning Letters

CLOSEOUT LETTER

Pulmuone Foods USA, Inc. MARCS-CMS 416366 —

Product:
Food & Beverages
Seafood/Seafood Product

Recipient:
Recipient Name
Hyoyul Lee
Recipient Title
North American Business Unit CEO
Pulmuone Foods USA, Inc.

2315 Moore Ave
Fullerton, CA 92833
United States

Issuing Office:
Office of Human and Animal Food Operations – West Division 5

1201 Harbor Bay Parkway
Alameda, CA 94502
United States


Dear Hyoyul Lee:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter, dated February 6, 2014. Based on our evaluation, it appears that you have addressed the violations 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/
For: Darla R. Bracy
District Director | FDA San Francisco District
Program Division Director
Office of Human and Animal Food Operations – West Division 5