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CLOSEOUT LETTER

Fagron, Inc MARCS-CMS 545906 — Jun 13, 2019

Fagron, Inc - 545906 - 06/13/2019

Delivery Method:
VIA UPS
Product:
Drugs

Recipient:
Recipient Name
Rafael Padilla
Recipient Title
CEO
Fagron, Inc

Fagron BV
Lichtenauerlaan 182
3062 ME Rotterdam
Netherlands

Issuing Office:
Center for Drug Evaluation and Research

300 River Place
Suite 5900
Detroit, MI 48207
United States

(313) 393-8100

Dear Mr. Padilla:

The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter [Case# 545906] dated August 29, 2018. Based on our evaluation, it appears that you have addressed the violation(s) 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/
Nicholas F. Lyons
Compliance Director
Division of Pharmaceutical Quality Operations III

cc: Teresa Fiedler, President
      Fagron North America
      Fagron Inc.
      2400 Pilot Knob Road
      St. Paul, MN 55120