FDA 483 - Ruspak Corporation - August 07, 2025

Ruzpak Corporation, a drug repacker/relabeler in Lyons, NY, was cited for quality control unit failures during an FDA inspection. The firm failed to establish adequate change control for the installation of tape on product contact surfaces used for packaging OTC products. This resulted in unapproved material use and a lack of assessment for potential product quality impact or cross-contamination risks.