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  5. Magellan Diagnostics, Inc. - 532743 - 08/03/2021
  1. Warning Letters

CLOSEOUT LETTER

Magellan Diagnostics, Inc. MARCS-CMS 532743 —

Delivery Method:
Via Email
Product:
Medical Devices
Recipient:
Recipient Name
John (Jack) P. Kenny
Recipient Title
CEO
Magellan Diagnostics, Inc.
Meridian Bioscience

3471 Riverhills Dr.
Cincinnati, OH 45244
United States

jack.kenny@meridianbioscience.com
Issuing Office:
New England District Office

United States

Dear Mr. Kenny:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS #532743) issued on October 23, 2017, at Magellan Diagnostics, Inc., 101 Billerica Avenue, Building 4, North Billerica, Massachusetts, FEI 1218996. 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 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,
/S/
Gina M. Brackett
Director, Compliance Branch
Office of Medical Device & Radiological Health
Division-1 East
Office of Regulatory Affairs
U.S. Food and Drug Administration

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