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  5. Perla Del Sur Foods L.L.C. - 562174 - 01/31/2020
  1. Warning Letters

CLOSEOUT LETTER

Perla Del Sur Foods L.L.C. MARCS-CMS 562174 —

Delivery Method:
VIA UNITED PARCEL SERVICE
Reference #:
20-HAFE4-WLCOL-02
Product:
Food & Beverages

Recipient:
Recipient Name
Mr. Ernesto Vázquez Borrero
Recipient Title
President
Perla Del Sur Foods L.L.C.
Don Julio Tropical Food LLC

Ext. La Guadalupe
Calle Guadalupe # 62
Ponce, PR 00730
United States

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

United States

(787) 729-8500

Dear Mr. Vázquez Borrero:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to 18-HAFE4-WL-04 dated August 15, 2018. During the current establishment inspection, we were informed that our firm is no longer operational. 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

 
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