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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Gills Onions, LLC - Close Out Letter 11/29/13

  

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


November 29, 2013


Steven H. Gill, Partner
Gills Onions, LLC
1051 Pacific Avenue
Oxnard, CA, 93030-7254


Dear Mr. Gill:

The Food and Drug Administration has evaluated your corrective actions to FDA Warning Letter #16-13 dated 01/23/13 including your responses presented during the regulatory meeting held in our district office on 02/28/13; the results of our September 2013 inspection and sample collections; and your responses to the September 2013 inspection at your facility. Based on our evaluation, it appears that you have addressed the violation(s) contained in the Warning Letter you received. 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