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  5. Barkey GmbH & Co. KG - 657073 - 07/30/2024
  1. Warning Letters

CLOSEOUT LETTER

Barkey GmbH & Co. KG MARCS-CMS 657073 —

Delivery Method:
Via UPS and EMAIL
Product:
Biologics
Recipient:
Recipient Name
Christian Barkey/Thomas Barkey
Recipient Title
Chief Executive Officer/Managing Director
Barkey GmbH & Co. KG

Gewerbestr. 8
North Rhine-Westphalia
33818 Leopoldshohe
Germany

thomas.barkey@barkey.de
Issuing Office:
Center for Biologics Evaluation and Research (CBER)

United States

Secondary Issuing Offices

United States

Dear Mr. Christian Barkey and Mr. Thomas Barkey:

The United States Food and Drug Administration (FDA) has reviewed your firm’s corrective actions in response1 to our Warning Letter issued to you on January 31, 2024. Based on our evaluation, it appears that you have addressed the violation(s) detailed in the Warning Letter.2 Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of your corrective actions.

This letter does not relieve you or your firm from the responsibility of taking all necessary steps to ensure sustained compliance with the Federal Food, Drug, and Cosmetic Act, its implementing regulations, or 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/
Melissa Mendoza
Director
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research


Cc: Robert Woodward
Managing Director
Azenta Inc.
15 Elizabeth Drive
Chelmsford, MA 01824
rob.woodward@azenta.com

  • 1Your corrective actions are detailed in correspondences dated February 23, 2024, April 5, 2024, May 14, 2024, May 29, 2024, and July 5, 2024.
  • 2Your response indicates that you have ceased distribution of the plasmatherm V in the U.S. Additionally, you have initiated a recall of the device from U.S. customers. We expect you to see this through to completion.
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