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

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