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  5. Picket Fence Creamery LLC - 618726 - 07/15/2022
  1. Warning Letters

CLOSEOUT LETTER

Picket Fence Creamery LLC MARCS-CMS 618726 —

Delivery Method:
VIA UPS
Product:
Dietary Supplements
Recipient:
Recipient Name
Jeffrey S. Burkhart and Jill L. Burkhart
Recipient Title
Co-Owners
Picket Fence Creamery LLC

14583 S. Avenue
Woodward, IA 50276
United States

Issuing Office:
Division of Human and Animal Food Operations West II

United States

Dear Mr. and Ms. Burkhart,

The Food and Drug Administration has completed an evaluation of Picket Fence Creamery LLC corrective actions in response to our Warning Letter (CMS case #: 618726) on January 14, 2022. 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/
Matthew R. Sleeter
Acting Program Division Director
Office of Human and Animal Food
West Division II

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