Danish Wheelchair Maker Warned on Documentation, Supplier Evaluation

R82, a Gedved, Denmark, wheelchair manufacturer, has received an FDA warning letter for quality violations, including evaluating suppliers by the wrong standards.

The company’s quality procedure shows that it evaluates suppliers based on purchase volume and the possibility of supplier replacement. However, R82 does not evaluate suppliers based on their ability to meet quality metrics and other requirements, according to the Oct. 18 warning letter posted Oct. 22.

Fifteen of the company’s products are being held at the U.S. border until the violations are corrected, the letter says. These include several wheelchair models, mechanical chairs, bath chairs and standing frames. The FDA may need to reinspect the facility to verify the corrective actions, the warning letter adds.

The FDA investigator also cited R82 for a CAPA failure, noting the company did not verify the effectiveness of steps it took to solve problems documented in several CAPAs. “These CAPAs demonstrate that your firm took steps to correct the underlying problems, but did not document test results to verify that the changes were effective, or verify or validate that the changes did not affect the finished device,” the agency says.

The company’s quality procedure requires that solutions be verified with testing and performance evaluation.

R82 also failed to evaluate certain complaints to determine whether investigations were needed, and it did not document the reasons for not conducting investigations.

A few of the warning letter citations related to the company’s Rabbit mobile standing frame. R82 could not show the FDA investigator the methods it used to develop, conduct, control and monitor production processes to ensure the frame conforms to specifications. It also was unable to provide the device master record for the Rabbit frame and could not provide documents for a project plan, user requirement specifications, design inputs, design outputs, design review, design verification, design validation or design transfer, the letter says.

Yes, your products can be impounded at the U.S. border simply for a misunderstanding with a supplier. Medical Device Quality & Compliance Institute 2013 Quality Systems and Design Control Training will take you through procedures to follow to keep your distribution systems open. Register now.