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  5. Hilgenkamp Farm Inc - 539250 - 07/30/2020
  1. Warning Letters

CLOSEOUT LETTER

Hilgenkamp Farm Inc MARCS-CMS 539250 —

Delivery Method:
VIA UPS
Recipient:
Recipient Name
Milton D. Hilgenkamp, Ronald G. Hilgenkamp
Recipient Title
Co-Owners
Hilgenkamp Farm Inc

8748 County Road 13
Arlington, NE 68002
United States

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

United States

913-495-5100

Dear Mr. Milton Hilgenkamp
and Mr. Ronald Hilgenkamp:

The Food and Drug Administration has completed an evaluation of Hilgenkamp Farms, Inc. corrective actions in response to our Warning Letter (CMS case #: 539250) on November 15, 2017. 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/
Miguel A. Hernandez
Director, Compliance Branch
Office of Human and Animal Food
Division II West

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