West Food Company - Close Out Letter 12/18/14
- West Food Company
Department of Health and Human Services
|Public Health Service|
|Food and Drug Administration|
5100 Paint Branch Parkway
College Park, MD 20740
December 18, 2014
Ms. Le Kim Loan, Director
West Food Company
Cai Son Hang Bang Industrial Zone
An Binh Ward, Ninh Kieu District
Can Tho, Vietnam
Reference No: #445434
Dear Ms. Le Kim Loan:
This letter is to inform you that the U.S. Food and Drug Administration (FDA) grants your request to remove your facility and your firm’s low-acid canned food (LACF) and acidified food (AF) products from detention without physical examination (DWPE) under IA 99-38, Detention Without Physical Examination of Low-Acid Canned Foods or Acidified Foods due to Inadequate Process Control. Your documentation submitted via email on December 2 and 4, 2014 satisfactorily resolves the problems described in our DWPE notification letter dated November 25, 2014. Your correspondence included documents addressing that SID 2005-08-01/001 was developed by an individual qualified to do so, and processing records to support that the manufacturing of your firm’s baby corn products adhered to SIDs 2005-07-25/005 and 2005-07-25/006. The FDA has also evaluated your response in regards to our Warning Letter #437687, issued October 2, 2014.
Based on the review the submitted documentation, we have determined that your firm has satisfactorily addressed the violations contained in the Warning Letter and resolved the issues that caused us to subject your firm and products to DWPE under IA 99-38, Detention Without Physical Examination of Low-Acid Canned Foods or Acidified Foods due to Inadequate Process Control.
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.
If you have any questions regarding this letter, please contact me either by email at Catherine.Vieweg@fda.hhs.gov or by phone at 240-402-4948.
Food Adulteration Assessment Branch
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition