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CLOSEOUT LETTER

Lake Fish Company Inc MARCS-CMS 489196 —


Recipient:
Recipient Name
Mr. Dale D. Trent
Recipient Title
President
Lake Fish Company Inc

1014 W Water Street
Sandusky, OH 44870
United States

Issuing Office:
HAF East Division V

United States

(513) 679-2700

Dear Mr. Trent:

The Food and Drug Administration has completed an evaluation of your firms’ corrective actions in response to our Warning Letter (CIN-16-489196-09) issued on February 17, 2016. 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/
Allison C. Hunter
Compliance Officer
HAF East Division V