PETNET Solutions Inc.

CLOSEOUT LETTER PETNET Solutions Inc. MARCS-CMS 584016 — May 17, 2022 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Drugs Recipient: Recipient Name Mr. Barry Scott Recipient Title Chief Executive Officer PETNET Solutions Inc. 810 Innovation Drive Knoxville , TN 37932 United States Issuing Office: Division of Pharmaceutical Quality Operations I United States 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 Content current as of: 05/24/2022 Regulated Product(s) Drugs