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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Hiossen, Inc. - Close Out Letter 11/19/13

  

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

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

Telephone: 215-597-4390

 

Via United Parcel Service


November 19, 2013


IkJin Kim, Ph.D.
Director, Production Headquarters
Hiossen, Inc.
85 Ben Fairless Drive
Fairless Hills, PA 19030-5012


Dear Dr. Kim:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter 13-PHI-01, issued on October 5, 2012. 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