The FDA flagged problems with equipment calibration, design history files and record-keeping at the WAVi Co. 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.