In a March 25 letter, the FDA said that the device was revealed as adulterated during an inspection of the company’s facility in Ann Arbor, Mich., conducted Aug. 30, 2007 through Oct. 26, 2007.
“Xoran has recently undergone such an audit, where the FDA identified some areas for improvement, primarily related to supplementing the documentation of our FDA files. There were no findings of safety violations, and therefore there will be no interruption in the production, sales, or service of our products,” Susie Vestevich, public relations manager at Xoran, told Health Imaging News.
The following are among the 10 violations the agency noted:
Failure to document the results of the design validation in the Design History Files (DHF), including identification of the design, method(s), the date and the individual(s) performing the validation. For example, the MiniCAT CT system DHF did not contain test methods, equipment specifications to support equivalency and supporting test data such as supporting image scans.
Failure to maintain a complete Device Master Record (DMR). For example, the DMR does not include or refer to the location of all device and software specifications, all production and process specifications, or all installation, maintenance and servicing procedures and methods.
Failure to ensure that the installation, inspection and required testing are performed in accordance with the manufacturer's instructions and procedures and that the inspection and test results are documented to demonstrate proper installation. For example, the company failed to perform and document the Orbital Calibration test during onsite installation of the MiniCAT CT System.
The FDA said it received a Dec. 13, 2007 letter from Amy Kim, MD, manager of regulatory affairs at Xoran, responding to the Inspectional Observations, which was issued at the closeout of the inspection. The response letter describes commitments toward corrective action and implementing procedures, policies and documentation systems to improve the effectiveness of the quality, according to the agency.
However, the FDA concluded that the response was “inadequate because there are no specific steps outlined to correct the violations and prevent their recurrence.”
The agency also noted that failure to promptly correct the violations may result in regulatory action being initiated by FDA “without further notice,” including seizure, injunction and/or civil money penalties.
“We are committed at all times to meeting or exceeding the thresholds for safety and efficacy set out by the FDA, ISO and all other applicable regulatory agencies,” said Vestevich.