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  5. Tec Laboratories, Inc. - 568666 - 07/29/2022
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Tec Laboratories, Inc. MARCS-CMS 568666 —

Delivery Method:
Electronic Mail

Recipient Name
Steven D. Smith
Recipient Title
President and CEO
Tec Laboratories, Inc.

7100 Tec Labs Way, SW
Albany, OR 97321
United States

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.

CDR Steven E. Porter, Jr.
Director, Division of Pharmaceutical Quality Operations IV

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