FDA Investigates Contract Manufacturer of 3D Printed Titanium Orthopedic Implants

Dayton, OH, April 24, 2019 --(PR.com)-- The U.S. Food & Drug Administration (FDA) conducted an Establishment Inspection of Tangible Solutions' premises located at 678 Yellow Springs Fairfield Road, Fairborn, Ohio 45324. The contract manufacturing firm’s Additive Manufacturing (3D Printing) equipment validations and records were subject to review, along with many other controls and procedures.

According to the FDA’s Website, the FDA inspects manufacturers or processors of FDA-regulated products to verify that they comply with relevant regulations. Since Tangible Solutions is registered with the FDA, they are subject to such inspections.

Upon conclusion of the Establishment Inspection Report, zero FDA-483’s were issued. FDA Form 483s are issued when FDA investigator(s) observe any conditions, that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) 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.” -Adam Clark, CEO of Tangible Solutions.

About Tangible Solutions

Tangible Solutions is a Contract Manufacturer of 3D Printed Titanium Orthopedic Implants. The company is registered with the FDA, ISO 13485:2016 and ISO 9001:2015 certified. Founded in 2013, the company serves Orthopedic Implant OEMs who need a supplier focused on the medical device market. Tangible prides itself on providing value beyond 3D Printing with in-house machining, post-processing capabilities, and lifecycle management of Orthopedic Implant products. Raising the bar of part quality, on-time delivery, and customer service...with a smile.
Tangible Solutions
Drew Matula