Lake Fish Company Inc

CLOSEOUT LETTER Lake Fish Company Inc MARCS-CMS 489196 — April 01, 2020 More Warning Letters Warning Letters About Warning and Close-Out Letters 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 Content current as of: 04/10/2020