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  5. Pure Source LLC - 555240 - 11/15/2019
  1. Warning Letters

CLOSEOUT LETTER

Pure Source LLC MARCS-CMS 555240 —

Delivery Method:
VIA UPS
Product:
Drugs

Recipient:
Recipient Name
Joel J. Meyerson
Recipient Title
Owner
Pure Source LLC

9750 NW 17th Street
Doral, FL 33172-2753
United States

Issuing Office:
Center for Drug Evaluation and Research

United States


Mr. Meyerson:

The Food and Drug Administration has completed the evaluation of corrective actions in response to our Warning Letter (WL # 555240), dated February 20, 2019. Based on our evaluation, 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.

Sincerely,
/S/
John W. Diehl, M.S.
Director, Compliance Branch
Office of Pharmaceutical Quality Operations,
Division II

CC: Renee Alsobrook, Chief
       Department of Business and Professional Regulation
       Division of Drugs, Devices and Cosmetics
       Compliance and Enforcement
       2601 Blair Stone Road
       Tallahassee, Florida 32399-1047