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  5. RTI Surgical, Inc. dba RTI Biologics, Inc. - 525318 - 04/12/2019
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RTI Surgical, Inc. dba RTI Biologics, Inc. MARCS-CMS 525318 —

Recipient Name
Mr. Camille Farhat
Recipient Title
President and CEO
RTI Surgical, Inc. dba RTI Biologics, Inc.

11621 Research Circle
Alachua, FL 32615
United States

Issuing Office:
Center for Biologics Evaluation and Research (CBER)

555 Winderley Place
Suite 200
Maitland, FL 32751
United States

Dear Mr. Farhat:

The Food and Drug Administration has completed an evaluation of your firm's actions in response to our Warning Letter [OBPO-1 18-01] dated, November 8, 2017, for adulteration and misbranding of a drug product. Based on our evaluation of your firm's manufacturing and distribution operations on November 27, 2018, the Agency acknowledges that you have ceased manufacturing and distributing the map3 Allograft product. We acknowledge that you voluntarily discarded through incineration, your remaining inventory of map3 Allograft product under FDA observation on December 19, 2018. Because your firm is no longer performing the activities specified in the Warning Letter, you are no longer required to implement corrective actions to address the violations at this time. However, if your firm resumes operations as described in the Warning Letter, it must be in full compliance with current good manufacturing practices and address all the concerns described in the Warning Letter.

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. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.

Elizabeth Waltrip
Program Division Director

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