You survived the FDA inspection. Now what? FDA always finishes the inspection by leaving you with a list of its observations. Part 3 concludes the survival guide series by describing the steps every company should take after the inspectors leave ó
from developing a corrective action plan to writing a detailed response document.
Would your company survive a surprise inspection? An FDA inspection can be a nightmare that costs
your company money,
time, and reputation. Proactive managers understand the logic
behind FDA regulations
and prepare accordingly.
When an FDA inspection
is imminent, it pays to have a plan. Start by getting your paper in order and your facility in a state of good repair. Train a team to manage interaction with inspectors. Coach your employees on how to answer questions. And donít forget to