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

Industry Worries FDA Will See Drug GMP Violations Captured By Security Cameras

Executive Summary

A review of recent US FDA citations has industry concerned about the extent to which agency investigators may be reviewing security video archives as part of their pharmaceutical manufacturing plant inspections.

You may also be interested in...



Emergent COVID-19 Vaccine Plant’s Quality Issues Draw Unusual Spotlight From US FDA Topsiders

Remediation must be quick and sure, say FDA’s Woodcock and Marks, despite challenges with facilities, equipment, processes and personnel training.

Do Not Be So Quick To Blame Microbes On The Lab, The US FDA Warns Emcure

Emcure's Hinjwadi, India, plant should have investigated other more likely sources of contamination more thoroughly, the FDA says.

The Quality Lowdown: Quality Vision Falls Short At Various US and Indian Facilities

Court overrides stem cell clinic’s dismissal of drug GMPs, the US FDA upbraids drug makers for quality unit shortfalls, and a variety of snafus trigger drug recalls.

Related Content

Topics

UsernamePublicRestriction

Register

PS121505

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