FDA 483 - EKF Diagnostics, Inc. dba EFK Life Sciences - December 13, 2019

EKF Diagnostics, Inc. dba EFK Life Sciences in Elkhart, IN was inspected from December 10-13, 2019. The inspection revealed significant deficiencies in the firm's corrective and preventive action (CAPA) procedures. Specifically, the firm failed to adequately establish and follow its own policies regarding preventive actions, risk analysis for product impact, and justification for extended completion dates for various actions.