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CLOSEOUT LETTER

West Coast Laboratories Inc


West Coast Laboratories Inc

  

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

 
 Food and Drug Administration
Los Angeles District
Pacific Region
19701 Fairchild
Irvine, CA 92612-2506

Telephone: 949-608-2900
          FAX: 949-608-4415 

 

VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED

April 23, 2015

Mr. Maurice E. Ovadia, President/Owner
Mr. Ronnie E. Ovadia, Technical Director
West Coast Laboratories, Inc.
116 E. Alondra Blvd.
Gardena, CA 90248


Dear Mssrs. Ovadia:

The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter (WL # 35-14), dated 09/15/14. 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.


Sincerely,

/S/

Alonza E. Cruse, Director
Los Angeles District