FDA 483 - Best Dental Kit LLC - May 01, 2025

Best Dental Kit LLC in Shavertown, PA, a repacker of dental kits, was cited for significant deficiencies in its quality control unit, complaint handling, storage conditions, and employee training. The inspection revealed a complete lack of written procedures and records for critical quality operations, inadequate personnel qualifications, and a failure to ensure proper environmental controls for drug products. These issues indicate a systemic breakdown in the firm's adherence to current Good Manufacturing Practices.