Tec Laboratories, Inc.

CLOSEOUT LETTER Tec Laboratories, Inc. MARCS-CMS 568666 — July 29, 2022 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Electronic Mail Product: Drugs Recipient: Recipient Name Steven D. Smith Recipient Title President and CEO Tec Laboratories, Inc. 7100 Tec Labs Way, SW Albany , OR 97321 United States steve@teclabsinc.com Issuing Office: Division of Pharmaceutical Quality Operations IV United States Dear Mr. Smith: The U.S. Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our warning letter dated March 20, 2019. Based on our evaluation, it appears that you have adequately addressed the violations contained in this warning letter. You are expected to take all necessary steps to ensure compliance with the Federal Food, Drug, and Cosmetic Act and FDA’s implementing regulations. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means. Sincerely, /S/ CDR Steven E. Porter, Jr. Director, Division of Pharmaceutical Quality Operations IV Content current as of: 08/17/2022 Regulated Product(s) Drugs