FDA Warns Hungarian Devicemaker for Poor Design, Process Controls

The FDA issued a warning letter to a devicemaker in Pest, Hungary, for serious quality system failures, including inadequate design and process controls.

An inspection of the Mandelay facility revealed software problems related to a biofeedback device. The firm’s software failure analysis and corrective action report indicated that corrections were made to the software but didn’t include full details.

The facility also failed to document or investigate software-related complaints, the agency said.