Part 3, responding to observations

Lavian and Allen present several pointers that a company should take after a Food and Drug Administration evaluation, specifically presenting details in developing a corrective action plan, and also writing a detailed response document. They stress that responding to observations made by inspectors is often the most difficult part of completing the inspection process, but it is critical at this stage to remember the potential benefits that can result from an audit that may cover better and more frequent employee training and more efficient operation, documentation, process improvements, and new scientific and technological advances.