FDA 483 - Tarmac Products, Inc. - July 22, 2022

Tarmac Products, Inc. in Miami Gardens, FL, an OTC and cosmetic manufacturer, was cited for significant deficiencies across its facilities, quality control, and laboratory systems during an FDA inspection. Observations included poorly maintained and unsanitary buildings with pest infestations, and critical failures in quality control procedures and master records for bisacodyl suppositories. These issues, including the use of an unvalidated microbial test method and pre-dated testing results, indicate a severe lack of adherence to Good Manufacturing Practices, potentially compromising drug product quality and safety.