Inspections, Compliance, Enforcement, and Criminal Investigations
Evergreen Acres Dairy LLC - Close Out Letter 4/29/10
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Public Health Service Food and Drug Administration |
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Minneapolis District Office |
Department of Health and Human Services
April 29, 2010
Keith L. Schaefer
Owner
Evergreen Acres Dairy, LLC
26162 240th Street
Paynesville, Minnesota 56362
Dear Mr. Schaefer:
We received the March 21, 2010, letter by Shelly Spoden, Herd Manager, to supplement your response to Warning Letter MN 10-01, issued on October 9, 2009. Thank you for your response. Your letter has been made a part of the Minneapolis District's permanent file for your firm.
The Food and Drug Administration has completed an evaluation of your corrective actions in response to the Warning Letter. 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.
If you have any questions about this matter, please contact me at (612)758-7132.
Sincerely,
/s/
Brian D. Garthwaite, Ph.D.
Compliance Officer
Minneapolis District
BDG/ccl
