CLOSEOUT LETTER
Corin Ltd
- Recipient:
- Corin Ltd
United States
- Issuing Office:
United States
| Public Health Service Food and Drug Administration |
| 10903 New Hampshire Avenue Silver Spring, MD 20993 |
Department of Health and Human Services
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