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CLOSEOUT LETTER

LifeCell Corporation 14/02/2017

LifeCell Corporation - Close Out Letter 2/14/17


LifeCell Corporation

 

  

Black HHS-Blue FDA Logo

 

 

 
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993 

FEB 14 2017

Frances E. Harrison, RAC
Vice President
Quality, Regulatory and Tissue Services
LifeCell Corporation
95 Corporate Drive
Bridgewater, New Jersey 08807

Dear Ms. Harrison:

The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter (CMS # 459704) dated June 05, 2015. 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 yours,
/s/
CAPT Raquel Peat, PhD, MPH, USPHS
Director
Division of Premarket and
Labeling Compliance
Office of Compliance
Center for Devices and
Radiological Health