Inspections, Compliance, Enforcement, and Criminal Investigations
Spence & Co., Ltd. - Close Out Letter 8/9/13
Department of Health and Human Services
|Food and Drug Administration|
New England District Office
One Montvale Avenue, 4th floor
Stoneham, MA 02180
August 9, 2013
Ms. Jean McClain
Spence & Co., Ltd.
76 Campanelli Industrial Dr.
Brockton, MA 02301
Dear Ms. McClain:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter, CMS # 391735, dated January 15, 2013. 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.
Amber G. Wardwell
Director, Compliance Branch
New England District
Mr. Jonathan Dee
Alliance Select Foods International, Inc.
Suite 1405, East Tower
Philippine Stock Exchange Centre
Pasig City, Metro Manila, Philippines 1600