Tarmac Products, Inc.

CLOSEOUT LETTER Tarmac Products, Inc. MARCS-CMS 595993 — September 18, 2025 More Warning Letters Warning Letters About Warning and Close-Out Letters Reference #: FEI 1025483 Product: Drugs Recipient: Recipient Name Mr. Adalberto R. Cabrera Recipient Title Chief Operating Officer Tarmac Products, Inc. 16311 NW 52nd AVE Miami Gardens , FL 33014-6209 United States Issuing Office: Division of Medical Device and Radiological Health Operations Central United States Secondary Issuing Offices United States Dear Mr. Cabrera: The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (Case 595993), dated November 9, 2020. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections. 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 FDA 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. Sincerely, /S/ Marisa Heayn Compliance Officer Division of Drug Quality II Content current as of: 09/25/2025 Regulated Product(s) Drugs