Inspections, Compliance, Enforcement, and Criminal Investigations
Ocean Fresh, LLC - Close Out Letter 11/25/11
| Public Health Service Food and Drug Administration |
San Francisco District |
Department of Health and Human ServicesCERTIFIED MAIL
RETURN RECEIPT REQUESTED
November 25, 2011
Robert S. Juntz, Jr. and Susan A. Juntz, Owners
Ocean Fresh, LLC
350 N. Main Street
Fort Bragg, California 95437
Dear Mr. and Mrs. Juntz:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter, dated December 2, 2010. 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.
Sincerely,
/s/
Darlene B. Almogela
Director, Compliance Branch
San Francisco District
