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

Tyco/Radionics Seeks Quality System Auditor Following FDA Warning Letter

This article was originally published in The Gray Sheet

Executive Summary

Tyco Healthcare Group subsidiary Radionics should stop shipping certain products that FDA believes pose sterility concerns, the agency suggests in a warning letter dated March 8 and released March 26

You may also be interested in...



FDA Talks Tough To Tyco, Cites Baxter For QS Lapses In Warning Letters

Baxter has implemented 100% leak testing as part of its efforts to respond to a recent FDA warning letter that detailed quality systems infractions

Finance Watch: Silverback, Kinnate, Sigilon Launch December’s First IPOs

Public Company Edition: Lixte’s small uplisting was the only biopharma initial public offering in the US during Thanksgiving week, but IPOs are ramping up again. Also, LifeSci launched its second SPAC and in follow-on offerings Reata brought in $281m and Intellia grossed $175m.

UsernamePublicRestriction

Register

LL1135009

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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