A mock FDA inspection, or mock FDA audit, is an audit and preparation process used by companies within FDA-regulated industries to assess their compliance with FDA regulations and overall readiness for an actual FDA inspection. A well-run mock FDA inspection will identify any potential shortcomings or gaps that could be problematic during a real inspection so they can be addressed before regulators arrive.
Our in-depth guide covers the basics of mock FDA inspections, the reasons to conduct one, and exclusive best practices and recommendations from our team.
We've helped hundreds of FDA-regulated firms of all sizes rapidly access the industry's best auditors to plan and conduct mock FDA inspections. We provide a timely, comprehensive, and enlightening audit experience that alleviates inspection stress and reveals every opportunity for improvement. If remediation is necessary and expert outside assistance is desired, we can continue providing that support as needed.
Our consultants simulate an actual FDA inspection at your site or facility, conducting a sort of inspection pressure test and rehearsal combined with a training component to close gaps and enhance every element of readiness. In some cases, these internal mock audits can even be more stringent than actual regulatory inspections, going far deeper into the quality system and sometimes sparking large-scale remediation and/or training projects.
Teams work with us to manage their inspection readiness when they’re ready for a higher level of professionalism and the peace of mind that comes with an auditing partner whose commitment to quality and integrity reflects their own.
Unparalleled Expertise
Our network includes over 250 former FDA personnel, ensuring authentic inspection experiences that truly mirror what you can expect from the FDA.
Customized Approach
We tailor our mock inspections to your specific product type — drugs, devices, or biologics — ensuring relevance and maximum value.
Comprehensive Coverage
Our mock inspections cover all aspects of a real PAI, from documentation review to on-site facility assessments, leaving no stone unturned.
Actionable Insights
Receive detailed reports with observations and deficiencies categorized by criticality, along with suggested corrective and preventive actions.
Rapid Response
With an average consultant presentation time of just 26 hours, we can quickly mobilize to meet your needs, even on short notice.
Learn how The FDA Group partnered with a large healthcare product Company to support a Pre-Approval Inspection (PAI) audit preparation project and subsequent quality system remediation efforts at a site within the European Union.
At The FDA Group, we pride ourselves on our deep bench of auditors, many of whom are former FDA professionals. Their intimate knowledge of the FDA inspection process and regulations provides invaluable insights and mimics the style of actual FDA investigators.
Our consultants simulate an actual FDA inspection at your site or facility, conducting a sort of inspection pressure test and rehearsal combined with a training component to close gaps and enhance every element of readiness. In some cases, these internal mock audits can even be more stringent than actual regulatory inspections, going far deeper into the quality system and sometimes sparking large-scale remediation projects.
Whether you're preparing for an internal mock inspection to evaluate your own facility or need to conduct an external mock FDA inspection of a supplier or vendor, our team of experienced consultants is ready to help.
Is your team using Veeva as your eQMS? In addition to conducting audits, we can complete your data entry directly within your Veeva system, saving you significant time and attention.
Our dedicated project support team works directly with our auditors to streamline the process of inputting audit reports into the Veeva platform. We’ll guide your Veeva Administrator through the steps to confer the necessary user permissions in the platform and take care of the audit input on your behalf.
Contact us to learn more about integrating Veeva management into your auditing service so you can focus on your core operations.