Medtech Insight is part 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

Boston resolves long-standing FDA warning

This article was originally published in Clinica

Executive Summary

Boston Scientific has been notified by the US FDA that all issues concerning a warning letter issued in 2006 have been resolved. The Natick, Massachusetts-based firm was originally warned about problems with procedures, processes and timelines in its quality system at three of its US manufacturing facilities (www.clinica.co.uk, 3 February 2006). In its 2009 annual report filed with the US Securities and Exchange Commission, Boston said that it had identified solutions to the quality system issues cited by the FDA and have made significant progress to implement these solutions. The firm also said that since it received the warning letter, its manufacturing plants had been reinspected several times and had met FDA approval.

Advertisement
Advertisement

Topics

Advertisement
UsernamePublicRestriction

Register

MT095386

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