FDA 483 - Qiagen Sciences LLC - July 16, 2021

An FDA inspection of Qiagen Sciences LLC in Germantown, MD, from July 12-16, 2021, revealed significant deficiencies in the firm's corrective and preventive action (CAPA) procedures. The firm's CAPA process failed to consistently require corrective/preventive actions and effectiveness verification, and product risk assessments were not updated following labeling changes for the AmniSure ROM Test.