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

Business Bites: St Jude resolves warning letter; DePuy Synthes recalls jaw device

This article was originally published in Clinica

Executive Summary

The US FDA has told St Jude Medical that violations cited in a 2009 warning letter for the firm’s Plano, Texas neuromodulation device facility have been resolved. The warning letter, based on an inspection of the firm’s Plano plant, highlighted several violations to the quality system regulation. In April, St Jude CEO Daniel Starks said the firm had taken remediation steps at the Texas plant and was awaiting a reinspection of the facility by FDA.

Advertisement

Topics

Advertisement
UsernamePublicRestriction

Register

MT101870

Ask The Analyst

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

Your question has been successfully sent to the email address below and we will get back as soon as possible. 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