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  5. Molteno Ophthalmic Limited - 450427 - 08/02/2019
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CLOSEOUT LETTER

Molteno Ophthalmic Limited MARCS-CMS 450427 —

Delivery Method:
United States Postal Service
Product:
Medical Devices

Recipient:
Recipient Name
Tess E.S. Molteno
Recipient Title
Managing Director
Molteno Ophthalmic Limited

152 Frederick Street
Dunedin 9016
New Zealand

Issuing Office:
Center for Devices and Radiological Health

10903 New Hampshire Avenue
Silver Spring, MD 20993
United States


Dear Mrs. Molteno:

The Food and Drug Administration. (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter (CMS 450427, dated February 27, 2015). Based on our evaluation, it appears that you have addressed the violation(s) 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 yours,
/S/
Ronald L. Swann, M.S.
Acting Director
Division of International Compliance
Operations
Office of Compliance
Center for Devices and Radiological Health