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CLOSEOUT LETTER

Energist Limited Jan 08, 2015

Energist Limited - Close Out Letter 1/8/15


Energist Limited

  

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

 
 Food and Drug Administration
10903 New Hampshire Avenue
White Oak Building 66
Silver Spring, MD 20993

JAN 08, 2015
 

Via United Parcel Service


Mark Phillips
Chief Executive Officer
Energist Limited
2 Park Pavilions, Clos Llyn Cwm
Enterprise Park
Swansea SA6 8QY
United Kingdom


Dear Mr. Phillips:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter, CMS # 358418, dated December 12, 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/

Carl Fischer, Ph.D.
Director
Division of International Compliance Operations
Office of Compliance
Center for Devices and Radiologic Health