FDA warns CardiacAssist on unreported patient death

FDA regulators issue a formal warning letter against CardiacAssist after inspectors find that the company failed to report a patient death.

Pennsylvania-based CardiacAssist landed in the FDA's cross hairs this month after agency inspectors found that the company failed to file a report after learning of a patient death.

CardiacAssist Inc., Food & Drug Administration (FDA)

News Well, Cardiac Assist Devices, Food & Drug Administration (FDA), Regulatory/Compliance, Warning Letter

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