U.S. Food and Drug Administration broadens the consent decree with Getinge and includes its subsidiary Datascope
U.S. Food & Drug Administration (FDA) will include Getinge’s subsidiary Datascope as an additional facility in the company’s existing consent decree with the U.S Government. This is due to findings from previous FDA inspections and a warning letter related to operational compliance with the company’s quality management system and processes.Getinge has today responded to FDA and accepted that Datascope will be included in the existing Consent Decree. FDA’s conclusion relates to a previously communicated warning letter in 2019 and subsequent inspections at the Datascope site in Wayne, NJ, US,