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  5. Lac-Mac Limited - Close Out Letter 7/3/17
  1. Warning Letters

CLOSEOUT LETTER

Lac-Mac Limited


Lac-Mac Limited

 

  

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VIA UNTED STATES POSTAL SERVICE

JULY 3, 2017

Michael Garvey
Lac-Mac Limited
847 Highbury Avenue North
Building 2
London, Ontario N5Y 5B8
Canada

Dear Mr. Garvey:

The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter CMS #446956, dated April 1, 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 sustainabi lity 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 wi ll 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 

cc
US Agent Rene Van De Zande
Emerge Group, Inc.
816 Congress Ave. Ste. 1400
Austin, TX 78701