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  5. Flayco Products, Inc. - 534460 - 12/10/2019
  1. Warning Letters

CLOSEOUT LETTER

Flayco Products, Inc. MARCS-CMS 534460 —

Delivery Method:
VIA UNITED PARCEL SERVICE
Reference #:
20-HAFE4-WLCOL-01
Product:
Food & Beverages

Recipient:
Recipient Name
Mr. Jorge Astorquiza Sr.
Recipient Title
President
Flayco Products, Inc.

4823 N. Hale Ave.
Tampa, FL 33614-6517
United States

Issuing Office:
Office of Human and Animal Feed Operations East Division IV

United States

(787) 729-8500

Dear Mr. Astorquiza:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to Warning Letter 17-OHAFOEDIV4-WL-08 dated August 18, 2017. It appears that you have addressed the violations 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.

 

Kind regards,

/S/

Edwin Ramos

Director of Compliance Branch

Office of Human and Animal Feed Operations, East Division IV