Wheelchair Lift Firm Warned 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.

Although the devicemaker promised in its 483 response to rectify the problem, FDA deemed the response inadequate due to insufficient detail.

The FDA also took issue with ThyssenKrupp Access’ corrective and preventive action plans, finding they lacked requirements for analyzing data on nonconforming product and for verifying CAPAs.

Despite claims that it regularly reviews the data, the company’s records showed “no defined action limits or thresholds for indications of quality problems,” the warning letter states. Plans to improve CAPA procedures also lacked details. The FDA cited the same problem during a 2007 inspection of the plant.

CAPA programs remain the No. 1 issue triggering warning letters and many drug and device companies remain hard pressed to understand what additional steps they should take to finally satisfy the FDA.

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