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Collagen Matrix, Inc. MARCS-CMS 496451 —

Medical Devices

Collagen Matrix, Inc.

United States

Issuing Office:

United States



Black HHS-Blue FDA Logo


Office of Medical Device and Radiological
Health Operations (OMDRHO) Division 1-East
One Montvale Avenue
Stoneham, MA 02180 


November 1, 2017

Bareld J. Doedens
Collagen Matrix, Inc.
15 Thornton Road
Oakland, NJ 07436

Dear Mr. Doedens:

The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter (16-NWJ-15) dated September 20, 2016. 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.

William C. Macfarland
Acting Director, Compliance Branch
Office of Medical Device and Radiological
Health Operations (OMDRHO) Division 1- East 

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