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  5. Prismatik Dentalcraft, Inc - 186163 - 10/18/2017
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CLOSEOUT LETTER

Prismatik Dentalcraft, Inc MARCS-CMS 186163 —

Recipient:
Prismatik Dentalcraft, Inc

United States

Issuing Office:

United States

 

   

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VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED

October 18, 2017

Gregory P. Minzenmayer
Chief Operating Officer
Prismatik Dentalcraft, Inc.
2212 Dupont Dr.
Irvine, CA 92612-1525

Dear Mr. Minzenmayer:

The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter (WL #18-14), dated 03/27/2014. 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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