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  5. Dolezal Dairy - 558107 - 08/27/2019
  1. Warning Letters

CLOSEOUT LETTER

Dolezal Dairy MARCS-CMS 558107 —

Delivery Method:
VIA UPS
Product:
Animal & Veterinary
Recipient:
Recipient Name
Jeffery A. Dolezal, Mark G. Dolezal, Mark R. Dolezal
Recipient Title
Co-Owners
Dolezal Dairy

947 - 24th Road
Pender, NE 68047
United States

Issuing Office:
Center for Veterinary Medicine

8050 Marshall Drive
Suite 205
Lenexa, KS 66214-1524
United States

913-495-5100

Dear Messrs. Dolezal

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CMS 558107 dated August 29, 2018. 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 letter, please contact Tamara J. Umscheid, Compliance Officer at (913) 495-5128 or Tamara.Umscheid@fda.hhs.gov.

Sincerely,
/S/
Miguel A. Hernandez
Director, Compliance
Office of Human and Animal Food – Division II West

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