Prepare For My Inspection
What You Are Dealing With
You have an FDA inspection coming and the clock is running. Your team is managing their day-to-day workload while simultaneously trying to make sure everything is in order before investigators arrive. You know your operation, but an inspection covers a lot of ground and there is real pressure to make sure nothing gets missed. What you need is a clear picture of where you stand right now and a focused plan to close any gaps before the FDA walks through the door.
How We Approach It
We conduct and identify key areas thorough assessment of your quality systems and identify what investigators are most likely to focus on. We close the gaps that carry the most risk, prepare your documentation, and make sure your team can respond to investigator questions accurately and confidently. You go into the inspection knowing exactly where you stand.
What We Have Done
A pharmaceutical client engaged MEDVACON ahead of an FDA Pre-Approval Inspection. Our team assessed the quality system, identified gaps, and implemented a focused remediation. The client passed the inspection.
A mid-sized life sciences manufacturer engaged MEDVACON to prepare for an upcoming FDA inspection with no defined trigger. Our team conducted a full inspection readiness assessment, performed a gap analysis across quality systems and documentation, and supported remediation and staff preparation. The client entered the inspection prepared and with significantly reduced compliance risk.