The FDA has warned Meridian Medical Systems, a maker of X-ray systems, for vague supplier monitoring procedures and other quality issues.
The Aurora, Ohio, company’s purchasing process and supplier evaluation process map “is ambiguous on how you will monitor your suppliers,” according to a July 3 FDA warning letter. “Your process map lists the ‘input’ for monitoring trends of performance as identifying performance parameters for suppliers. These parameters are not defined.”
Meridian also lacks quality data records to show its suppliers are being monitored and has no records to show how any of its suppliers were qualified, the letter says. It follows a May 13 through May 31 inspection by the FDA’s Cincinnati district office.
While the company’s purchasing process shows the evaluation of suppliers by capability survey, trial order and past performance, it has no documentation of these activities. Further, it has not reviewed or approved any validated processes associated with its suppliers’ manufacturing of components or accessories.
The FDA letter also chides Meridian for lacking a method to gather information from quality data sources. Servicing and installation are performed by distributors, but they have provided no quality data records to the company, and there is no contractual obligation for them to provide this information, the letter says.
The letter further cites Meridian for lacking:
Procedures for final product testing and quality release;
A design history file for the Meridian DR 200 single panel X-ray system; and
Procedures to describe the content of its device history records (DHR).
All of the eleven DHR files reviewed by the FDA investigator were incomplete, as the only record was for testing of the flat panel detectors. The agency notes this is only one part of the X-ray system. Additionally, the DHRs do not include records related to installation, nonconformities, the X-ray hardware, workstation or acquisition software, or final product testing and quality release.
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