Pink Sheet 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

FDA Aggressively Looking for Data Integrity Problems in Inspections

This article was originally published in The Gold Sheet

Executive Summary

FDA inspectors using a new forensic approach to inspections in responding to a rash of data integrity problems found in pharmaceutical manufacturing facilities. Attorneys advise firms to pay careful attention to their adverse event reports and field alert reports as data integrity breaches can be found there too.

You may also be interested in...



New Jersey OTC Firm Lacked GMP Basics, FDA Warning Letter Says

US FDA warns that Health Pharma USA was shipping product before its quality unit could review and test it.

Removal Of ‘Legal’ And ‘Implicit’ Terms Cleared Way For ICH Q12 Guideline

Concerns about potential regional variation and ambiguous applicability subside with final revision of lifecycle management guideline; training preparations begin.

World's Pharmaceutical Inspectorates Focus On Increased Mutual Reliance

Launching desktop assessments to ease the inspectional workload of regulators and forging stronger relationships with India and China are two key priorities for the international inspectorate group this year.

UsernamePublicRestriction

Register

PS000842

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