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  5. GVS Filter Technology UK Ltd - 02/14/2017
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CLOSEOUT LETTER

GVS Filter Technology UK Ltd

Recipient:
GVS Filter Technology UK Ltd

United States

Issuing Office:

United States

  

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

Public Health Service
Food and Drug Administration
 10903 New Hampshire Avenue
Silver Spring, MD 20993 

FEB 14, 2017

Via United Parcel Service

John Pike
UK Managing Director
GVS Filter Technology UK, Ltd.
NFC House, Vickers Industrial Estate
Mellishaw Lane
Morecambe
Lancashire
LA3 3EN
United Kingdom

Dear Mr. Pike:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter# 445394, sent on January 23, 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,
/S/

Matthew Krueger, M.S.E.
Acting Director
Division of International Compliance
Operations
Office of Compliance
Center for Devices and Radiological Health

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