483
EKF Diagnostics, Inc. dba EFK Life SciencesEKF Diagnostics, Inc. dba EFK Life Sciences – FDA 483, Dec 13, 2019
Record Details
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.
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ID · 05ecee85-9aff-4db0-a50b-c3ab38e1dbee
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