Most FDA inspections occur without prior notification. Are you ready?
Managing the inspection can be stressful and complex. Do you know what to do when the FDA visits your company?
The FDA conducts inspections for many reasons. PAREXEL Consulting’s former FDA Investigators and industry compliance experts can help you prepare for all types of FDA inspections. In addition to pointing out possible vulnerabilities, we can prepare your team to effectively manage the inspection.
Preapproval Inspections (PAIs)
The outcome of a preapproval inspection will determine if your NDA, BLA, PMA, or other submission is approved. Are you confident you can demonstrate to the FDA that:
A mock Preapproval Inspection by our experts will answer these questions and provide guidance to address any vulnerabilities that are discovered, before the FDA arrives.
GMP Inspections
The FDA uses a Quality System based approach to GMP inspections, employing 6 predefined Quality Systems in various combinations. Do you know what these 6 Quality Systems are, and are you confident of your state of compliance?
A GMP inspection by one of our experts provides the answers and the guidance you need to ensure a successful inspection.
“For Cause” Inspections
Did you receive an FDA-483 or a Warning Letter following your last FDA inspection? Has your company conducted a recall? Have you taken appropriate and lasting corrective action? Are you certain the issues will not be found again when the FDA returns?
Our experts can help you determine if your response to your last inspection or recall was effective, and if further action is needed, we can help you plan and implement it to eliminate the risk of a more serious regulatory action by the FDA.
For more information, contact one of our experts today.
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Link to our FDA Inspections Readiness experts
