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

FDA Drug GMP Warning Letters Increase 6%, Focus on Supply Chain and Sterility Assurance in FY 2011

This article was originally published in The Gold Sheet

Executive Summary

The number of drug GMP warning letters issued by FDA continued to climb in fiscal year 2011, with supply chain and sterility assurance issues dominating the agency’s attention. FDA is requesting a budget increase in FY 2013 to expand its inspectional presence abroad to better meet global supply chain threats, and agency officials are saying that failure to monitor contract manufacturers is a major problem shown in recent warning letters, but that failure to investigate out-of-specification results is still the No. 1 finding.

You may also be interested in...



Difficulty Identifying Experts Seen as a Factor in Poor Investigations

Pharmaceutical enterprises have become so complex that some sites with quality problems can’t find the root cause because they no longer know who their key experts are or where to find them, one industry expert says. Regardless of why they happen, inadequate investigations continue to be the most frequently cited GMP concern in FDA warning letters year after year.

Friend or Foe? The Role of Regulatory Relief in Drug Shortages

FDA’s Janet Woodcock argues that strong enforcement prevents drug shortages, dismissing allegations that crackdown under Hamburg triggered shortage crisis. There is more agreement, however, on the role of other factors such as group purchasing organizations, or GPOs, in the crisis.

Lack of Microbiological Controls Had Grave Consequences for Compounders

The current public health crisis stemming from microbiological contamination of sterile injectables at drug compounding pharmacies demonstrate the importance of having robust aseptic sterile processing programs, said an FDA official. Some problems at drug manufacturers were also highlighted showing inadequate microbiological controls.

Related Content

UsernamePublicRestriction

Register

PS000672

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