FDA 483 - EKF Diagnostics, Inc. dba EFK Life Sciences - November 09, 2022

An FDA inspection of EKF Diagnostics, Inc. dba EFK Life Sciences in Elkhart, IN, from November 7-9, 2022, identified significant deficiencies in the firm's control of nonconforming product. The inspection revealed inadequate procedures and documentation for rework activities, investigations into nonconformances, and the disposition of nonconforming products. These issues indicate a lack of robust quality system controls for managing products that do not meet specified requirements.