Pescatlantic Group, LLC

CLOSEOUT LETTER Pescatlantic Group, LLC MARCS-CMS 496990 — May 26, 2020 More Warning Letters Warning Letters About Warning and Close-Out Letters 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 Content current as of: 05/29/2020 Regulated Product(s) Drugs