Breaking News

FDA Completes Re-inspection of AMRI Facility

Issues Form 483 for three inspectional observations

Author Image

By: Tim Wright

Editor-in-Chief, Contract Pharma

The FDA has completed a re-inspection of Albany Molecular Research, Inc.’s (AMRI) pharmaceutical manufacturing facility in Burlington, MA. Conducted from July 11, 2013 through July 18, 2013, the FDA inspected the facility, operations and quality systems, including a systematic review of corrective actions related to the previously disclosed 2011 Form 483. Following this latest inspection, the company received a Form 483 for three inspectional observations. No observations were issued following i...

Continue reading this story and get 24/7 access to Contract Pharma for FREE


Already a subscriber? Sign in

Keep Up With Our Content. Subscribe To Contract Pharma Newsletters