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FDA Warns Datascope Over Design Validation

February 22, 2019

The FDA came down on Datascope, a Getinge Group subsidiary, for failing to conduct proper design validation at its Mahwah, New Jersey facility.

The inspection, which was held from July 30 through Oct. 3, 2018, revealed that the facility’s design validation didn’t include testing of production units under actual or simulated use conditions to make sure they met user needs and intended uses.

Specifically, the firm did not develop a suitable test for its Cardiosave product — an intra-aortic balloon pump — to show that its new top cover protects against saline ingress.

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