FDA Cites Alber for Lack of Design Change Procedures
Lack of design change procedures and validation as well as inadequate complaint handling resulted in a 483 for German devicemaker Alber during an inspection of the firm’s facility in Albstadt, Baden-Wurttemberg.
The firm’s design change procedure for its mobility aids did not ensure that all changes were controlled or validated, the agency said. For example, design changes to the smart phone application used to control the cruise mode for the electric motor add-on were not controlled through the human factors engineering process, and design changes were released for production without adequate controls.
A review of CAPA procedures during the May 2017 inspection showed that at least three complaints for non-conforming products were marked “closed” but not all effectiveness checks were completed.