Datascope, a subsidiary of Getinge, receives a warning letter from the US Food and Drug Administration (FDA) at the Mahwah site in the US
Getinge’s production site in Mahwah, New Jersey, US, has received a warning letter from the US Food and Drug Administration. The warning letter originates from routine inspections during 2018 of the Datascope facilities in Mahwah and Fairfield.FDA’s observations are related to procedures and processes linked to requirements on supplier control, design controls and changes, and the corrective and preventive actions (CAPA) procedure. Prior to the 2018 FDA inspection, the company self-identified the deficiencies through internal audit performed by Getinge. Since the end of 2017 a remediation