The FDA sent Canada-based Savaria Concord Lifts a warning letter citing twelve violations regarding corrective and preventive actions (CAPAs), complaint evaluations, software validation, and other areas.
Following a February 2016 inspection of Savaria’s Ontario facility, the FDA said it failed to establish adequate CAPA procedures. For example, those procedures did not include requirements for key activities such as analyzing data to identify quality problems, validating CAPAs to ensure their effectiveness, and recording procedural changes to correct and prevent defects. In addition, certain CAPAs were not documented before they were closed.
The warning letter also cited a failure to adequately establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit. — Jeff Kinney