Responding To FDA 483s And Warning Letters: Some Dos, Don’ts And Red Flags
Executive Summary
Invalidated OOS results are ‘red flags’ during FDA inspections and ‘denying, delaying, limiting or refusing’ a drug inspection proposed by the agency could have serious consequence, participants at a recent webinar on best practices for responding to Form 483s and warnings letters heard.
You may also be interested in...
What The FDA’s Inspections Q&A Guidance Really Means: It’s Time To Offer Virtual Inspections
Compliance experts see possibilities in offering video tours as the FDA offers “holistic” approach to assessing sites during pandemic.
UK MHRA Relies On Remote Drug GMP Inspections As COVID-19 Pandemic Grounds Inspectors
Experience from previous viral outbreaks has allowed the UK agency to move quickly; long-term focus is on hybrid inspection approach.
US FDA Announces Plans To Resume Domestic Inspections
Agency resuming domestic inspections with the help of a pandemic rating system to identify localities where inspections will be safest for investigators and plant workers. Another safety factor: all inspections will be pre-announced.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: