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CLOSEOUT LETTER

Sharp Global Limited

Recipient:
Sharp Global Limited

United States

Issuing Office:

United States

 

  

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10903 New Hampshire Avenue
Building 51 Room 4359
Silver Spring, MD 20993-0002 

February 21, 2017

Major General Vinod K. Khanna
Director TQM
Sharp Mint Limited
C-03, SMA Co-operative Industrial Estate
G.T. Karnal Road
Delhi – 110 033
India

Reference: FEI 3010798127

Dear Major General Vinod K. Khanna:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter: 320-15-01, October 15, 2014. Based on our evaluation, it appears that you have addressed the deviations 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/

Christina Alemu-Cruickshank
Compliance Officer
Division of Drug Quality I 

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