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  5. B. Braun Medical Inc. - 501232 - 10/22/2020
  1. Warning Letters

CLOSEOUT LETTER

B. Braun Medical Inc. MARCS-CMS 501232 —

Delivery Method:
VIA UPS
Recipient:
Recipient Name
Peter A. Klaes
Recipient Title
Vice President and General Manager, Irvine Operations
B. Braun Medical Inc.

2525 McGaw Avenue
Irvine, CA 92614-5841
United States

Issuing Office:
Los Angeles District Office

United States

949-608-2900

Dear Mr. Klaes:

The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #30-17 dated May 12, 2017. 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 FDA 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/
CDR Steven E. Porter, Jr.
Director, Division of Pharmaceutical Quality Operations IV

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