The FDA flagged problems with equipment calibration, design history files and record-keeping at the WAVi facility in Englewood, California.
In a January inspection, investigators found the company’s design history files do not sufficiently prove that the company achieved regulatory compliance. The company did not establish or maintain design and development plans, and it failed to document and review design inputs to ensure the requirements addressed the device’s intended use.
The agency also found device master records did not address elements such as device/component specifications, production methods and procedures, or quality assurance procedures. Similarly, device history records did not demonstrate compliance with current good manufacturing practices.
The company had not properly established or maintained procedures for acceptance of incoming raw materials and components or documented inspection, testing and verification of conformance for those materials, the agency said.
The inspection also found that the volt meter used to test headsets for resistivity has not been calibrated in approximately three years, and there was no procedure in place for calibration. The company also lacked documentation of acceptable suppliers, contractors and consultants used in the manufacture of the headsets.
No electronic or controlled hardcopy of the company’s SOP for headset assembly was available for production staff, and the company’s quality audit procedures do not identify the internal audit interval. Moreover, no internal quality audits had been completed, according to the 483.