Inspections, Compliance, Enforcement, and Criminal Investigations

LCW, INC. - Close Out Letter 9/2/15

  

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

 
 Food and Drug Administration
Import Operations Branch
Los Angeles District
Long Beach Resident Post
One World Trade Center, Suite 300
Long Beach, CA 90831
Main Phone: (562) 256-7700
Fax: (562) 256-7701

VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED


September 2, 2015

Mr. Kevin H. Chen, President
LCW Inc., dba uFresh Center and LDF (Leaders Maker)
1011 E. Las Tunas Dr.
San Gabriel, CA 91776

Dear Mr. Chen:

The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter (WL# 07-15 dated February 6, 2015). Based on our evaluation, it appears that you have addressed the violation(s) 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.

If you have questions regarding this letter, please contact James Lin, Ph.D., Compliance Officer at (310) 647-2923.


Sincerely,

/S/

Alonza E. Cruse, Director
Los Angeles District

Cc: David M. Mazzera, Chief
      Food and Drug Branch
      California Department of Public Health
      PO Box 997435
      1500 Capitol Ave., MS-7602
      Sacramento, CA 95899-7413

Page Last Updated: 09/13/2015
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English