483
Qiagen Sciences LLCFDA 483 - Qiagen Sciences LLC - July 16, 2021
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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.
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ID · c79300a6-193b-4258-9bdb-8ec24a4c743f