Inspections, Compliance, Enforcement, and Criminal Investigations

USV Limited - Close Out Letter 2/14/18

 

  

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10903 New Hampshire Avenue
Silver Spring, MD 20993 

February 14, 2018

Mr. Prashant K. Tewari
Managing Director
USV Private Limited
Arvind Yi thal Gandhi Chowk, B.S.D. Marg,
Govandi, Mumbai 400 088
India

Reference: PEI: 3004086 192

Dear Mr. Tewari:

The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter: 320-17-29 dated March 10, 2017. Based on our evaluation, it appears that you have addressed the violations 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 FDA 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/
CDR Frank Verni, R.Ph., MPH
Compliance Officer
Division of Drug Quality II

Page Last Updated: 02/15/2018
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