Rigid FX Orthopedics, a medical device manufacturer based in Austin, Texas, has received a warning letter from the United States Food and Drug Administration due to issues at its Austin production facility. The company manufactures a product for the treatment of distal radius fractures, dubbed the Clearview Wrist Fixation System.
According to information from the FDA, the warning letter is dated from November 2nd of 2012. However, the letter was just posted this week. In the letter, the FDA admonished Rigid FX over its production regulatory systems. According to the FDA, Rigid FX does not have a system to ensure that all manufactured devices meet the design outlines for the FDA-approved device.
The FDA also cited the company for poor communication systems. The company did not have any procedures, systems or processes for handling complaints. Rigid FX is required to report the steps it has taken to correct these violations. In addition, the company is required to make changes to avoid similar issues in the future.
- Drowning in Big Data: Extracting Medical Device Quality and Safety Insights - Webcast
- Quality with Confidence – What You Need to Know About Digital Microscopes for Medical Device Quality Processes - Webcast
- Risk Management for Medical Device Manufacturers - Webcast
- 3 Steps for Designing the Ideal Medical Device Packaging System - Webcast
- Reducing Device Cost with Innovative Medical Materials - Webcast
- Automating your Quality Management System: Pitfalls & Essentials - Webcast