Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Abbott GMP Warning Letter Accelerates Monitoring Systems Validation Work

This article was originally published in The Gray Sheet

Executive Summary

Abbott is accelerating enhancements to its monitoring systems validation program at the company's Austin, Texas facility following receipt of an FDA warning letter related to production of hospital products, including I.V. drug solutions

You may also be interested in...



Hospira Assumes Responsibility For Recent Abbott Warning Letter

Abbott spin-off Hospira will be accountable for resolving FDA quality oversight and manufacturing concerns related to the firm's intravenous administration sets

Hospira Assumes Responsibility For Recent Abbott Warning Letter

Abbott spin-off Hospira will be accountable for resolving FDA quality oversight and manufacturing concerns related to the firm's intravenous administration sets

Abbott Consent Decree Costs Escalate With Failed FDA QSR Inspection

Costs related to Abbott's FDA consent decree could approach $1 bil. in lost revenue alone following a failed follow-up inspection of the company's Lake County, Illinois diagnostic manufacturing operations

Latest Headlines
See All
UsernamePublicRestriction

Register

MT017387

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