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Namsa MARCS-CMS 544884 —


Recipient Name
Pinaki Chakraborty, MS, Ph.D., MBA
Recipient Title
Vice President, Global Quality and Regulatory Compliance

400 Highway 169
Suite 500
Minneapolis, MN 55426
United States

Issuing Office:
Center for Devices and Radiological Health

United States

Dear Dr. Chakraborty:

The FDA has completed an evaluation of your firm’s corrective and preventive actions in response to our Warning Letter (WL) dated March 23, 2018, and the follow up inspection conducted on August 30, 2021, to September 21,2021. Based on our evaluation, it appears that your firm has adequately addressed the violations contained in the WL and in the one item FDA Form-483, dated September 21, 2021, and has implemented the corrective actions, as promised in your response letters, dated October 11, 2021, December 31, 2021, April 3, 2022, and July 7, 2022.

This letter does not relieve your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 321(h), and its implementing regulations. The FDA expects your firm to maintain compliance and this letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.

Sincerely yours,
Sheena Green, MS
Assistant Director
DCEA1: Division of Clinical Policy and Quality
OCEA: Office of Clinical Evidence and Analysis
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

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