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  1. Warning Letters

CLOSEOUT LETTER

ACell, Inc


ACell, Inc

  

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

 
 Food and Drug Administration
Baltimore District Office
Central Region
6000 Metro Drive, Suite 101
Baltimore, MD 21215
Telephone: (410) 779-5455
Fax: (410) 779-5705

FEI: 3005920706


June 1, 2016

Certified Mail
Return Receipt Requested

James DeFrancesco, CEO
ACell, Inc.
6640 Eli Whitney Drive, Suite 200
Columbia, MD 21046

Dear Mr. DeFrancesco:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter CMS# 392488 dated April 26, 2013. Based on our evaluation, it appears that you have adequately addressed the violation(s) 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/
Cherlita Honeycutt
Compliance Officer
Baltimore District