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  5. Bioptigen Inc. - 04/19/2016
  1. Warning Letters


Bioptigen Inc.

Bioptigen Inc.

United States

Issuing Office:

United States


Department of Health and Human Services' logoDepartment of Health and Human Services

 Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993

APR 19 2016

Mr. Eric L Buckland
President and CEO
Bioptigen, Inc.
663 Davis Drive
Suite 480
Morrisville, North Carolina 27560-6884

Dear Mr. Buckland:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter [WL # 105346 - February 9, 2011]. Based on our evaluation, it appears that you have addressed the violation 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 through other means.

Sincerely yours,


Keisha R. Thomas
Acting Director
Division of Premarket and
    Labeling Compliance
Office of Compliance
Center for Devices and
    Radiological Health

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