FDA conducted an Establishment Inspection of Tangible Solutions' premises in Fairborn, Ohio. The contract manufacturing firm’s additive manufacturing/3D printing equipment validations and records were reviewed, along with other controls and procedures.
FDA inspects manufacturers or processors of FDA-regulated products to verify that they comply with relevant regulations. As Tangible Solutions is registered with FDA, they are subject to such inspections.
Upon conclusion of the Establishment Inspection Report, Tangible Solutions was issued no FDA Form 483s, reflecting no observed violations of the Food Drug and Cosmetic Act and related Acts.
“The results of this inspection give our customers another layer of confidence in our capabilities and processes. Frankly, we are fanatics about quality and compliance. We will continue to improve and live by our core values, treating every implant as if it were going into our own body,” said Adam Clark, CEO of Tangible Solutions.
Source: Tangible Solutions