Tangible Solutions, Inc. DBA Marle Tangible, Inc. – FDA 483, Oct 5, 2022

An FDA inspection of Tangible Solutions, Inc. DBA Marle Tangible, Inc., a medical device manufacturer in Fairborn, OH, revealed significant deficiencies in their quality system. Observations included inadequate process validation for cleaning lines, insufficient supplier approval procedures, and a lack of control and monitoring over production processes. These issues indicate a need for comprehensive corrective actions to ensure product quality and regulatory compliance.