Racer Technology, a Singapore maker of cochlear implant accessories, expressed confusion about the term “device history record” during a recent FDA inspection, drawing a warning letter from the agency.
“The investigator referred your firm to 21 CFR 820.184 and read the entire section to your firm,” according to the Dec. 12 letter posted recently online. “Your firm then confirmed that it was unaware of this requirement.”
The FDA also rapped the company for its purchasing procedure, which did not adequately define supplier quality control. The procedure outlines quality reviews and a grading scale of poor, average or good; however, “there are no defined requirements for the sources of quality data that are to be reviewed to make this determination, nor are there any defined levels of what constitutes a poor, average, or good rating,” the letter states.
Meanwhile, the company’s supplier/vendor quality audit procedure gives requirements for periodic auditing of critical component suppliers, but when the FDA investigator asked which components were critical, Racer didn’t know.
Racer’s CAPA procedure lacks requirements for analyzing quality data, using appropriate statistical methodology and ensuring verification or validation before CAPAs are implemented, the warning letter continues. And the procedure does not require documentation for all CAPA activities.
During the June 3-6 inspection, the FDA investigator reviewed several sets of manufacturing and test records for three lots of earhook devices and battery charger accessory devices. The records did not identify equipment used during testing and did not identify the unit being tested, the letter says.
Flow diagrams that outline Racer’s complaint handling procedures lack requirements to ensure timely complaint processing, documentation and evaluation for MDR reportability, the letter adds. When complaints are not investigated, the diagrams don’t instruct employees to record why there was no investigation and the name of the person who decided not to investigate.
It always pays to read the fine print. But if you’ve ever missed any of the finer details of gaining acceptance of a device, there’s Regulatory Challenges of Device Acceptance.