How To Write An Effective Quality Investigation Report

In 2016, the FDA issued hundreds of Form 483 observations across the drug and device industries for inadequately reviewing or investigating issues. This particular deficiency consistently ranks among the top five most frequently cited observations year after year..

What is it about the investigation process that poses such a challenge for many organizations?

In this guide, we delve into why organizations often struggle with conducting effective investigations, explore common pitfalls that lead to inadequate reviews and investigations, and provide practical strategies to avoid these mistakes. Additionally, we offer a step-by-step approach to writing comprehensive and compliant investigation reports. By understanding and addressing these challenges, organizations can improve their investigation processes, ensure regulatory compliance, and ultimately enhance the quality and safety of their products.