FDA 483 - Tarmac Products, Inc. - November 04, 2025

Tarmac Products, Inc. in Miami Gardens, FL, a contract manufacturer of medical devices, was cited for seven significant deficiencies during an FDA inspection. The observations primarily concern inadequate quality system controls, including severe pest control issues, failures in medical device reporting, lack of management reviews and quality audits, and non-compliance with Unique Device Identifier (UDI) regulations. Several observations are repeat deficiencies, indicating persistent issues.