PETNET Solutions Inc. MARCS-CMS 584016 — May 17, 2022

CLOSEOUT LETTER

• Product: Drugs

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• Recipient: Mr. Barry Scott; Chief Executive Officer; PETNET Solutions Inc.; 810 Innovation Drive; Knoxville, TN 37932; United States

• Issuing Office: Division of Pharmaceutical Quality Operations I; United States

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Dear Mr. Scott:

The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter [CMS #584016], dated October 17, 2019. Based on our evaluation, it appears that you have adequately addressed the violations contained in this Warning Letter.

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.

Respectfully,
/S/
Lisa Harlan
Acting Program Division Director/District Director
U.S. Food and Drug Administration
OPQO Division I / New Jersey District

Cc:

Mr. Michael Nazerias
Vice President, Regulatory Affairs & Quality Assurance
PETNET Solutions, Inc.
810 Innovation Drive
Knoxville, TN 37932
michael.nazerias@petnetsolutions.com

Ms. Jessica Burger
Facility Site Manager
PETNET Solutions Inc.
350 Washington St. Unit 268
Woburn, MA 01801
jessica.burger@petnetsolutions.com