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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Samuel A. Fisher Farm - Close Out Letter 3/3/14

  

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

PHILADELPHIA DISTRICT
 Food and Drug Administration
900 U.S. Customhouse
2nd and Chestnut Streets
Philadelphia, PA 19106

Telephone: 215-597-4390

 

 

March 3, 2014


Delivered Via United Parcel Service


Mr. Samuel A. Fisher, Co-Owner
Samuel A. Fisher Farm
2100 Stiegel Pike
Myerstown, Pennsylvania 17067


Dear Mr. Fisher:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter 13-PHI-30, issued on September 13, 2013. 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/

Steven L. Carter
Director, Compliance Branch
Philadelphia District Office

 

cc: Barbara E. Fisher, Co-owner
      Samuel A. Fisher Farm
      2100 Stiegel Pike
      Myerstown, PA 17067