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

[email protected] Issuing Office: Center for Biologics Evaluation and Research (CBER)

United States

Secondary Issuing Offices

Dear Mr. Christian Barkey and Mr. Thomas Barkey:

The United States Food and Drug Administration (FDA) has reviewed your firm’s corrective actions in response 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. 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
[email protected]