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

bioMerieux Exploring QS Improvements Following IVD Facility Inspections

This article was originally published in The Gray Sheet

Executive Summary

bioMerieux is bringing in consultants to help resolve quality system issues identified by FDA after an April inspection of the firm's Durham, N.C. facility, the firm reported in a recent earnings release

You may also be interested in...



Class I recall

BioMerieux's VeriCal calibrator set recall has been designated Class I by FDA. The French company initiated the action in August because units are mislabeled and "could result in misdiagnosis or injury to patients, serious illness or death from erroneous calibration data leading to use of improper levels of oral anticoagulant drugs," the firm says. The in vitro diagnostic device, which has been distributed worldwide - including to 437 customers in the U.S. - is used to calibrate prothrombin time and activated partial thromboplastin time for coagulation assays. BioMerieux was involved in another Class I recall in March related to the mislabeling of MDA Simplastin human thromboplastin factor tissue reagents. The firm received warning letters from FDA in July 2004 and July 2005 citing quality system lapses at its Durham, N.C. manufacturing plant (1"The Gray Sheet" Aug. 30, 2004, p. 26)...

Aducanumab Review: Looking For Precedents – Long Ago And Far Afield

The run-away US FDA advisory committee review of Biogen’s Alzheimer’s candidate was highly unusual. But like most things at the agency, not entirely unprecedented.

UsernamePublicRestriction

Register

LL1132440

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