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CLOSEOUT LETTER

Pescatlantic Group, LLC MARCS-CMS 496990 —

Delivery Method:
VIA Electronic Mail
Reference #:
20-HAFE4-WLCOL-09
Product:
Drugs

Recipient:
Recipient Name
Mr. Cesar Calvo
Recipient Title
CEO
Pescatlantic Group, LLC

6100 Blue Lagoon Dr.
Suite #325
Miami, FL 33126
United States

shipments@pescatlantic.com
Issuing Office:
Office of Human and Animal Food Operations Division IV East

United States

(787) 729-8500

Dear Mr. Calvo:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to Warning Letter, FLA 16-17 dated June 14, 2016. 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 your responsibility of assuring that your establishment is in compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means. If you have any questions, please feel free to contact Ms. Pearl Lopina, Compliance Officer at telephone number (407) 475-4730 or at e-mail address pearl.lopina@fda.hhs.gov.

Kind regards,
/S/
Edwin Ramos
Director of Compliance Branch
OHAFO, Division IV East

 
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