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

Tarmac Products, Inc. in Miami Gardens, FL, a contract manufacturer of medical devices, was cited for multiple significant quality system deficiencies during an FDA inspection. Key issues include inadequate pest control leading to potential product contamination, failures in medical device reporting, lack of management reviews and quality audits, and non-compliance with Unique Device Identifier (UDI) requirements. Many of these deficiencies were repeat observations from previous inspections, indicating systemic problems.