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  5. Cafe Valley Bakery, LLC - 603875 - 11/07/2023
  1. Warning Letters

CLOSEOUT LETTER

Cafe Valley Bakery, LLC MARCS-CMS 603875 —

Delivery Method:
VIA Electronic Mail
Product:
Food & Beverages
Recipient:
Recipient Name
Brian Owens
Recipient Title
CEO
Cafe Valley Bakery, LLC

7000 W. Buckeye Road
Phoenix, AZ 85043
United States

bowens@cafevalley.com
Issuing Office:
Office of Human & Animal Food Operations East 6

United States

Dear Mr. Owens:

The United States Food and Drug Administration (FDA) has completed evaluation of your firm’s corrective actions in response to our Warning Letter FY2020-HAFE6-02, issued on 03/18/2020. Based on our evaluation, it appears you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the continuing 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/
CDR Kelli L. Wilkinson
Director of Compliance
Office of Human and Food Operations
Division East 6

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