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  5. Organ Recovery Systems, Inc. - 519572 - 11/28/2018
  1. Warning Letters

CLOSEOUT LETTER

Organ Recovery Systems, Inc. MARCS-CMS 519572 —


Recipient:
Recipient Name
David Kravitz
Recipient Title
President and CEO
Organ Recovery Systems, Inc.
Organ Recovery Systems, Inc.

One Pierce Place
Suite 475W
Itasca, IL 60143
United States

Issuing Office:
Center for Devices and Radiological Health

550 W. Jackson Blvd.
15th Floor
Chicago, IL 60661
United States


Dear Mr. Kravitz:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter CHI-07-17 dated April 20, 2017. 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/
Blake Bevill, MS
Program Division Director
Office of Medical Device and Radiological Health
OMDRHO Division 2 - Central

CC: Pedro Juan Pardo, Director of Regulatory and Clinical Affairs
     : Christopher M. Hill, Director of Quality Assurance

 
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