Inspections, Compliance, Enforcement, and Criminal Investigations
Freshwater Fish Products, Inc. - Close Out Letter 4/16/13
Department of Health and Human Services
|Food and Drug Administration|
4040 North Central Expressway
Dallas, Texas 75204-3128
April 16, 2013
RETURN RECEIPT REQUESTED
Thomas E. Swan, Vice President and Chief Operating Officer
Freshwater Fish Products, Inc.
500 W. Main Street
Bradford, AR 72020
Dear Mr. Swan:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions since receiving Warning Letter 2012-DAL-WL-020 issued on May 1, 2012. Based on our evaluation, it appears that you have addressed the violation(s) 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.
Shari J. Shambaugh
Director, Compliance Branch
Dallas District Office