CLOSEOUT LETTER

A Nelson & Co., Ltd. May 09, 2016

Recipient:: A Nelson & Co., Ltd.; United States

Issuing Office:: United States


Department 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

Department of Health and Human Services