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  5. Access Bio, Inc. - 01/09/2017
  1. Warning Letters


Access Bio, Inc.

Access Bio, Inc.

United States

Issuing Office:

United States



Black HHS-Blue FDA Logo



New Jersey District Office
10 Waterview Blvd. 3rd Floor
Parsippany, New Jersey 07054


January 9, 2017

Mr. Young H. Choi
Access Bio, Inc.
65 Clyde Road Suit A
Somerset, NJ 08873

Dear Mr. Choi:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter [11-NWJ-05], issued on December 22, 2010. 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.


Stephanie Durso
Acting Director of Compliance
New Jersey District 

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