Rhode Island Firm Knocked for Design Control

Rhode Island device manufacturer Unetixs Vascular drew an FDA warning letter for failing to meet design requirements for its MultiLab Series ROODRA vascular diagnostic system.

The FDA found that the facility lacked design controls for the device and it failed to establish a design and development plan, design inputs or design outputs despite distributing the product since September 2018. In addition, it failed to review or validate its design and had no design history file.

Testing requirements were not established for manufacturing operations to ensure the vascular systems met important specifications, including electrical leakage, acoustic output, electromagnetic-compatibility and electrical safety, the agency said.