Pink Sheet 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

FDA Intends to Strengthen Recall Effectiveness Checks

Executive Summary

McKinsey & Co. submitted its Recall Business Process Improvement Study to FDA last year and delivered its recommendations this April.

You may also be interested in...



Drug Recalls Will Be Announced Without Classification Under FDA Pilot

FDA is pilot testing a program to speed notification of health care providers and patients about drug recalls.

Drug GMP Warning Letters, Enforcement Could Rebound in Obama's FDA

Reversal of downward enforcement trend expected after President Obama's team takes reins at FDA. After eight years of declining inspection activity, field staffing and warning letter issuance, industry is bracing for change. Obama demands "full review" of FDA over peanut recall. More criminal prosecutions expected. Congress plies agency with money for overseas inspections. FDA headquarters could unleash warning letters. New investigators will learn domestically while seasoned ones retire or head overseas. Focus of warning letters begins shifting abroad. Form 483 reports and warning letters continue to raise the same key issues. Production record review, data integrity, process validation concerns highlighted. Issues raised in 18 FY 2008 drug GMP warning letters detailed in chart beginning on page 12.

‘Shadow’ Factory Challenges Continue For US FDA

Agency wants more information about API suppliers as it winds up case against KV Tech for hidden use of Dr. Reddy’s plant and seeks to find disappearing manufacturer of contaminated OTC eye drops.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS053932

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