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CLOSEOUT LETTER

The Santa Barbara Smokehouse, Inc. Oct 03, 2017

The Santa Barbara Smokehouse, Inc. - Close Out Letter 10/3/17


The Santa Barbara Smokehouse, Inc.

 

  

Black HHS-Blue FDA Logo

 

Division of Human and Animal Food Operations West 5
19701 Fairchild, Irvine CA 92612-2506
Telephone: 949-608-2900 

 
 

UNITED PARCEL SERVICE
SIGNATURE REQUIRED

October 3, 2017

Timothy R. Brown, CEO/Owner
The Santa Barbara Smokehouse, Inc.
312 N N opal St.
Santa Barbara, CA 93103-3225

Dear Mr. Brown:

The United States Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter 43-12 dated September 12, 2012. 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 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 does not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
 

Sincerely,
/S/

Darla Bracy, Division Director
Office of Human and Animal Food Operations
Division West 5
U.S. Food & Drug Administration
 

cc:
David M. Mazzera, PhD, Chief, Food and Drug Branch
California Department of Public Health
1500 Capitol Avenue, MS-7602
P.O. Box 997435
Sacramento, CA 95899-7435