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  5. Campolor, Inc. - 575789 - 08/18/2021
  1. Warning Letters


Campolor, Inc. MARCS-CMS 575789 —

Delivery Method:
VIA Electronic Mail
Reference #:
21-HAFE4-WLCOL - 07
Food & Beverages

Recipient Name
Mr. Melvin Arroyo
Recipient Title
Campolor, Inc.

El Tuque Industrial Park, Bo. La Cuarta,
Calle A, Edificio 2
Ponce 00715
Puerto Rico

Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)

United States

(787) 729-8500

Dear Mr. Arroyo:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to Warning Letter No. 19-HAFE4-WL-06 dated March 8, 2019. 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,
Ramon Hernandez,
Program Division Director
OHAFO, Division IV East

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