FDA 483 - VENTURE SOLUTIONS - October 16, 2025

An FDA inspection of VENTURE SOLUTIONS in Urbancrest, OH, a manufacturer of Class II medical devices, revealed significant deficiencies in their quality system. The firm failed to establish procedures for device history records, adequately handle customer complaints, ensure proper employee training on quality system documentation, and develop written Medical Device Reporting procedures. These issues indicate a broad lack of fundamental quality system controls.