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CLOSEOUT LETTER

CXL-USA, LLC May 05, 2017

CXL-USA, LLC - Close Out Letter 5/5/17


Recipient:
CXL-USA, LLC


United States

Issuing Office:

United States


 

  

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10903 New Hampshire Avenue
Silver Spring, MD 20993 

MAY 5, 2017

Roy S. Rubinfeld, M.D.
President, CXL-USA, LLC
3131 Connecticut Ave., Apt. 2809
Washington, DC 20008

Dear Dr. Rubinfeld:

The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning letter dated April 1, 2015. Based on our evaluation, it appears that you have addressed the violation 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 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 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,
{See appended electronic signature page}
Adam Donat, M.S.
Branch Chief
Compliance Enforcement Branch
Division of Enforcement and Postmarketing Safety
Office of Scientific Investigations
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration
Building 51, Room 5352
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002

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This is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature.
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/s/
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ADAM C DONAT
05/05/2017