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CLOSEOUT LETTER

Iowa Orchard LLC Dec 16, 2014

Iowa Orchard LLC - Close Out Letter 12/16/14


Iowa Orchard LLC

  

Department of Health and Human Services' logoDepartment of Health and Human Services

 
 Food and Drug Administration
Southwest Region
Kansas City District
8050 Marshall Drive
Suite 205
Lenexa, Kansas 66214-1524
913-495-5100

 

December 16, 2014

CERTIFIED MAIL
RETURN RECEIPT REQUESTED


Bryan E. Etchens, Owner
Iowa Orchard LLC
9875 Meredith Drive
Urbandale, IA 50322-7226


Dear Mr. Etchens:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter CMS # 417854 issued April 7, 2014. 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.
 

Sincerely,

/S/

Cheryl A. Bigham
District Director
Kansas City District