Wheelchair Lift MakerWarned on CAPA, Complaint Handling
A bevvy of concerns about complaint handling and inventory led to an FDA warning letter for wheelchair-lift maker ThyssenKrupp Access Manufacturing.
The letter — issued by the FDA’s Chicago district office on March 27 and posted online April 10 — follows a Nov. 8-10, 2011, inspection of the company’s Grandview, Mo., plant and issuance of a Form 483.
ThyssenKrupp Access routinely did not investigate complaints about devices that failed to meet specifications, according to the letter. Moreover, its written procedures for complaint handling didn’t address the documentation of complaint investigations or how the decision not to investigate a complaint is made.
Although the devicemaker promised in its 483 response to rectify the problem, FDA deemed the response inadequate due to insufficient detail.
About 93 percent of FDA device warning letters fall into five categories: risk management, design control, supplier quality, QSR compliance and postmarket surveillance. We call them the “big five.”
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