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CLOSEOUT LETTER

Serpe & Sons Inc


Serpe & Sons Inc

  

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

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

Telephone: 215-597-4390

 

CERTIFIED MAIL
RETURN RECEIPT REQUESTED


April 16, 2015
 


Dominic Serpe, President
Serpe & Sons, Inc.
1411 Kirkwood Highway
Wilmington, DE 19805-2123


Dear Mr. Serpe:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter 14-PHI-06 issued April 4, 2014. 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