The following article shows three excerpts from some of the more common "observations" noted in Form 483 Letters during 2008-2009. After the excerpts, we’ll outline some best practices of a 483 response, providing you with a 10-point checklist that should make that 15-day time limit more manageable, and some links for further research. Finally, we’ll look at ways to simplify and automate monitoring, alarming and reporting on FDA regulated environments.
