FDA Cites Swedish Manufacturer Over Complaints, Records

The FDA hit Swedish manufacturer Boule Medical with a warning letter after the firm failed to investigate certain device complaints and maintain device history records.

The agency’s May 7-11 inspection discovered that the firm hadn’t investigated any of its U.S. service reports to determine why components failed, and chose to just repair or replace the faulty components. While the firm revised its complaint procedure, it didn’t provide evidence that staff members were trained in the revamped procedures.

The firm also had inadequate device history records to show devices were made according to the device master record. Specifically, Boule had no written DHR procedure and DHRs for its Medonic M-series hematology analyzers were missing information, such as the location of their sub-assemblies and primary identification labels.