FDA 483 - Life Technologies Corporation - June 14, 2021
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Life Technologies Corporation in Frederick, MD, a medical device manufacturer, was cited for deficiencies during an FDA inspection. The firm's corrective and preventive action (CAPA) procedures were found to be inadequate, failing to consistently require full CAPA activities and ensure timely record closure. Additionally, the company distributed Oncomine Dx Target Test Devices with incorrect expiration dates and/or lot numbers on labeling due to various internal errors.
ID · 83b40626-63d9-4252-bb67-c7f97ff1807a