How to Avoid and Respond to FDA Criticisms—Form 483 Letters—for Temperature, Humidity and other Controlled Environments

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. Veriteq Instruments.pdf