Inspections, Compliance, Enforcement, and Criminal Investigations

Holmes Produce LLC DBA Holmes Made Salsa - Close Out Letter 10/17/17

 

  

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Office of Human and Animal Food- West Division II
8050 Marshall Drive - Suite 205
Lenexa, Kansas 66214-1524
913-495-5100 

 
 

October 17, 2017

DELIVERY VIA UPS

WARNING LETTER CLOSE-OUT LETTER

Patricia D. Holmes, Owner
Holmes Produce dba Holmes Made Salsa
2252 N. Coolidge Ave
Wichita, KS 67204

Dear Ms. Holmes:

The Food and Drug Administration has completed an evaluation of Holmes Produce dba Holmes Made Salsa corrective actions in response to our Warning Letter (CMS case #: 489134) on March 23, 2016 and Regulatory Meeting (CMS case #: 511753) on January 5, 2017. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter and discussed during the Regulatory Meeting. 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/

Miguel A. Hernandez
Director, Compliance Branch
Office of Human and Animal Food-
West Division II 

Page Last Updated: 10/24/2017
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