FDA 483 - Lonza Bend Inc - January 24, 2020

An FDA inspection of Bend Research, Inc., a control testing laboratory in Bend, OR, identified two significant issues. The firm failed to perform routine inspection and checking of automatic equipment according to a written program, leading to numerous unaddressed system errors. Additionally, the firm did not maintain a backup file of critical data entered into its computer systems, resulting in a loss of historical log information.