Texas Devicemaker Scolded for Software Validation, Design Reviews

A Dallas, Texas manufacturer was hit with a Form 483 by the FDA over a failure to validate software.

The agency’s investigation of Immuno Concepts’ facility revealed a lack of documentation for software validation activities and computer data processing system results.

The firm also failed to conduct and maintain records of design reviews during the design and development of its Image Navigator device, an automated microscope that generates images of immunofluorescence slides.