FDA 483 - Tarmac Products, Inc. - February 06, 2026

Tarmac Products, Inc., a contract manufacturer located in Miami Gardens, Florida, underwent an FDA inspection from February 2 to February 6, 2026. The resulting FDA 483 report identifies several significant failures in quality control and manufacturing oversight. Key violations include the firm"s failure to perform specific identity testing on raw material components for over-the-counter (OTC) drug products, relying instead on unverified supplier reports even for high-risk materials. Additionally, the investigator found that the facility used unqualified and unvalidated devices to control temperature and humidity in stability chambers, potentially compromising the integrity of product testing.

The inspection also highlighted major administrative lapses by the Quality Unit, which failed to complete required Annual Product Reviews for the vast majority of the OTC drugs manufactured at the site. Furthermore, the company lacked scientific data or validated studies to support holding compounded drug materials in manufacturing tanks for several days without progressing to the next production phase. These observations were recorded under the regulatory framework of the Federal Food, Drug, and Cosmetic Act. While the document is not a final determination of non-compliance, Tarmac Products is expected to respond with a corrective action plan to address these safety and quality assurance deficiencies to ensure the strength, purity, and quality of their drug products.