U.S. flag An official website of the United States government
  1. Home
  2. Inspections, Compliance, Enforcement, and Criminal Investigations
  3. Compliance Actions and Activities
  4. Warning Letters
  5. Warren Farms, LLP - Close Out Letter 9/23/14
  1. Compliance Actions and Activities

CLOSEOUT LETTER

Warren Farms, LLP Sep 23, 2014

Warren Farms, LLP - Close Out Letter 9/23/14


Warren Farms, LLP

  

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

 
 Food and Drug Administration
New Orleans District
404 BNA Drive
Building 200 - Suite 500
Nashville, TN 37217

Telephone: (615) 366-7801
          FAX: (615) 366-7802

 

September 23, 2014


Ira Vaughn Warren, Owner
Warren Farms, LLP
799 Dove Circle
Union Grove, AL 35175-8342


Dear Mr. Warren:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter No. 2013-NOL-05, dated December 27, 2012. Based on our evaluation, it appears 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, I may be reached at (615) 366-7826.

 

Sincerely,

/S/

David P. Van Houten
Acting Director Compliance Branch
New Orleans District