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Centurion Medical Products Corporation MARCS-CMS 598837 —

Medical Devices

Recipient Name
Mr. Vishwanath Bhave
Recipient Title
Medline Divisional President
Centurion Medical Products Corporation

Three Lakes Drive
Northfield, IL 60093
United States

Issuing Office:
Division of Medical Device and Radiological Health Operations East

United States

Dear Mr. Bhave:

The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter dated June 11, 2020 (WL # 598837). 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 yours,
Gina Brackett
Director, Compliance Branch
Office of Medical Device & Radiological Health, Division 1
U.S. Food and Drug Administration

Cc: Karen Kowalczyk, Sr Dir QA Quality, Medline Industries, LP, KKowalczyk@medline.com

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