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CLOSEOUT LETTER

RemedyRepack Inc. May 21, 2015

RemedyRepack Inc. - Close Out Letter 5/21/15


RemedyRepack Inc.

  

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

 
 Food and Drug Administration
Silver Spring, MD 20993

 

CERTIFIED MAIL
RETURN RECEIPT REQUESTED


May 21, 2015


Susan Scott
RemedyRepack Inc.
655 Kolter Dr
Indiana, PA 15701-3570 USA


Ms. Scott,

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter Case_ID_422456. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections or 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/

Ilisa B.G. Bernstein, Pharm.D., J.D.
Deputy Director, Office of Compliance
Center for Drug Evaluation and Research
U.S. Food and Drug Administration


Cc: Philadelphia District Office

Attn: FDA Correspondence