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CLOSEOUT LETTER

Corin Ltd 09/02/2017

Corin Ltd - Close Out Letter 2/9/17


Corin Ltd

  

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 9, 2017

VIA UNITED PARCEL SERVICE

Mr. Stefano Alfonsi
Chief Executive Officer
Carin Medical Ltd.
Corinium Centre
Cirencester
GL7 1YJ
United Kingdom

Dear Mr. Alfonsi:

The Food and Drug Administration (FDA) has completed an evaluation of your firm 's corrective actions in response to our Warning Letter (CMS 461343, dated September 14, 2015). Based on our evaluation, it appears that your firm has adequately addressed the violations contained in this Warning Letter.

This letter does not relieve 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. The FDA expects your firm to maintain compliance and this letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.

Sincerely yours,
/S/

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

cc:

Lucinda Gerber
U.S. Agent
CORIN USA
5670 W. Cypress St.
Suite C
Tampa, FL 33607