- Delivery Method:
- VIA UPS
- Dietary Supplements
Recipient NameJeffrey S. Burkhart and Jill L. Burkhart
- Picket Fence Creamery LLC
14583 S. Avenue
Woodward, IA 50276
- Issuing Office:
- Division of Human and Animal Food Operations West II
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.
Matthew R. Sleeter
Acting Program Division Director
Office of Human and Animal Food
West Division II