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  5. Fleming Laboratories Ltd. - 01/15/2017
  1. Warning Letters


Fleming Laboratories Ltd.

Fleming Laboratories Ltd.

United States

Issuing Office:

United States



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Center for Drug Evaluation and Research
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002 

January 15, 2017

Mr. P. RamaKrishna
Fleming Laboratories Limited
Survey No. 270 Navabpet Village
Medak 502313 India

Dear Mr. Krishna,

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter# GDUFA-14-016. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections or 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.

Michael Levy
Deputy Director
Office of Compliance
Center for Drug Evaluation and Research

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