
Home » IVD Maker Hit for Change Control Procedures
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.
Upcoming Events
-
28Sep
-
28Sep
-
11Oct
-
16Oct
-
26Oct
-
02Nov