Barkey GmbH & Co. KG

CLOSEOUT LETTER Barkey GmbH & Co. KG MARCS-CMS 657073 — July 30, 2024 More Warning Letters Warning Letters About Warning and Close-Out Letters 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 response 1 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 1 Your corrective actions are detailed in correspondences dated February 23, 2024, April 5, 2024, May 14, 2024, May 29, 2024, and July 5, 2024. 2 Your 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. Content current as of: 08/05/2024 Regulated Product(s) Biologics