It goes without saying that FDA Inspections are critically important. Business impacts from a single inspection can range from millions to hundreds of millions of dollars in some cases. What is troubling is that many companies go from feeling confident in their ability to host a successful inspection, to receipt of an FDA 483, to later, a Warning Letter, or worse. We say often that companies don't know what they don't know about their readiness for an FDA inspection!
Becoming Inspection "Ever-Ready"
It has never been more important to be “ever-ready” for an FDA inspection. Although FDA now inspects less overall, their inspections are now much more intense, and FDA now uses dedicated product inspection teams to review your operation. Without expert guidance to help you prepare for these new inspection approaches, a company is at the mercy of aggressive FDA Investigators, potentially leading to significant remediation costs, distraction from business objectives, or worse, a possible business shutdown.
The Right Advisors for Your Next Inspection
Compliance Architects® can provide the leadership, resources and methodology to ensure your next inspection isn’t your last inspection. More than just an assessment, we can help you plan, prepare, and execute on a full set of readiness activities that will substantially improve your likelihood of success.