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  5. A Nelson & Co., Ltd. - 05/09/2016
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CLOSEOUT LETTER

A Nelson & Co., Ltd.

Recipient:
A Nelson & Co., Ltd.

United States

Issuing Office:

United States

  

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

Public Health Service
Food and Drug Administration
CENTER FOR DRUG EVALUATION AND RESEARCH
 Office of Manufacturing Quality
Division of Drug Quality II
Global Compliance Branch 3
10903 New Hampshire Avenue
Building #51, Room 4359
Silver Spring, MD 20993

TELEPHONE: (301) 796-0483
             FAX: (301) 847-8742

May 9, 2016

Mr. David A. Hinton
CEO
A Nelson & Co., Ltd.
5 Endeavor Way
Wimbledon, London SW19 8UH
United Kingdom

Reference: FEI 1000568184

Dear Mr. Hinton:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter: 320-12-22, issued July 26, 2012. 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 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/

Allison A. Aldridge, Ph.D.
Compliance Officer
Division of Drug Quality II
Global Compliance Branch 3
COER / OC / OMQ

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