IVD Maker Hit for Change Control Procedures

The FDA uncovered Lax change control procedures and document controls during an inspection of Bio-Med Diagnostics’ White City, Oregon facility.

Documentation to show that preventive actions were implemented to address gaps in training was lacking for the company’s InTray GC, a Class II in vitro diagnostic device for detecting gonorrhea.

FDA investigators said the firm failed to follow its change control procedures when implementing new software and didn't have a change control report or validation report documenting the change.