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  5. Staar Surgical Co. - 423326 - 06/15/2018
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CLOSEOUT LETTER

Staar Surgical Co. MARCS-CMS 423326 —

Product:
Medical Devices
Recipient:
Staar Surgical Co.

United States

Issuing Office:

United States

 

   

Black HHS-Blue FDA Logo

 

 
 
Los Angeles District
19701 Fairchild Road
Los Angeles, CA 92612 

VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED

June 15, 2018

Ms. Caren Mason, President and Chief Executive Officer
STAAR Surgical Company
1911 Walker Avenue
Monrovia, CA 91016

Dear Ms. Mason:

The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter (WL #20-14), dated 05/21/2014. 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,
/S/

Kelly D. Sheppard
Compliance Branch Director
Division 3/West
Office of Medical Device and Radiological Health Operations

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