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  5. OriGen Biomedical, Inc. - 569074 - 07/29/2020
  1. Warning Letters

CLOSEOUT LETTER

OriGen Biomedical, Inc. MARCS-CMS 569074 —

Delivery Method:
VIA Electronic Mail
Product:
Medical Devices
Recipient:
Recipient Name
Elizabeth San Segundo
Recipient Title
President and CEO
OriGen Biomedical, Inc.

7000 Burleson Rd.
Bldg. D
Austin, TX 78744
United States

Issuing Office:
Office of Medical Device and Radiological Health Operations Division 3West

United States

Dear Ms. San Segundo:

The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter dated December 20, 2018. 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/
Jessica Mu,
Director, Compliance Branch
Office of Medical Devices and
Radiological Health, Division III

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