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  5. Sagemax Bioceramics, Inc. - 439941 - 02/15/2018
  1. Warning Letters

CLOSEOUT LETTER

Sagemax Bioceramics, Inc. MARCS-CMS 439941 —

Delivery Method:
VIA UNITED PARCEL SERVICE
Product:
Medical Devices
Recipient:
Recipient Name
Sheng Dang
Recipient Title
President and Owner
Sagemax Bioceramics, Inc.

34210 9th Avenue South
Ste. 118
Federal Way, WA 98003
United States

Issuing Office:
Division of Medical Device and Radiological Health Operations West

United States

Dear Mr. Dang:

The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter (SEA #15-06), dated 12/09/2014. 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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