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CLOSEOUT LETTER

Montana Emu Ranch Company Inc Jan 31, 2018

Montana Emu Ranch Company Inc - Close Out Letter 1/31/18


Montana Emu Ranch Company Inc

 

  

Black HHS-Blue FDA Logo

 

 

 
Seattle District Office
22215 26th Avenue SE, Suite 210
Bothell, Washington 98021
 

January 31 , 2018

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Penelope S. Collins, Owner
Montana Emu Ranch Company
P.O. Box 7041
Kalispell, Montana 59904

Dear Ms. Collins:

The Food and Drug Administration has completed an evaluation of your firm 's corrective actions in response to our Warning Letter SEA 17-11 dated April 20, 2017. 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/

Miriam R. Burbach
Program Division Director
District Director