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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Landshire, Inc. - Close Out Letter 9/6/13

  

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

Food and Drug Administration
 Dallas District
4040 North Central Expressway
Dallas, Texas 75204-3128

 

September 6, 2013


CERTIFIED MAIL
RETURN RECEIPT REQUESTED


Joseph E. Trover, Jr., Chief Executive Officer
Landshire, Inc.
727 North First Street
St. Louis, MO 63102


Dear Mr. Trover:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions since receiving Warning Letter 2012-DAL-WL-11 , dated January 17, 2012, regarding operations at your facility located at 4117 Garland Drive, Ft. Worth, TX. 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 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/

Shari J. Shambaugh
Director, Compliance Branch
Dallas District Office