Medtech Insight is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

St. Jude Warning Letter Spotlights CAPA Flaws At CardioMEMS Unit

This article was originally published in The Gray Sheet

Executive Summary

The warning letter highlights validation and recordkeeping problems at the Atlanta manufacturing facility for the CardioMEMS heart failure remote monitoring system, but it is not expected to affect device availability.

Advertisement

Related Content

Warning Letter Roundup & Recap – October 20, 2015
St. Jude Sees New Techs Keeping It One Step Ahead Of The Field
St. Jude Builds Chronic Pain Business With NeuroTherm Acquisition
FDA Takes Enforcement Action Against CardioMEMS For Alleged Clinical Trial Violations

Topics

Related Companies

Related Deals

Advertisement
UsernamePublicRestriction

Register

MT034308

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

All set! This Question has been sent to my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel