A mock FDA Pre-Approval Inspection (PAI) is a simulated inspection process that a pharmaceutical or medical device company conducts internally or with the help of consultants before undergoing the official FDA inspection required for product approval. A mock PAI prepares the company for the actual FDA inspection by identifying and addressing any gaps or issues in its processes, facilities, documentation, or compliance that could lead to delays, regulatory action, or rejection of approval.
A mock PAI helps uncover any potential compliance gaps that might not be evident through regular internal audits. It ensures that processes related to GM), quality systems, data integrity, and other regulatory requirements are fully aligned with FDA expectations.
Our mock inspectors also train staff on how to handle FDA investigators and ensure that all necessary documentation is in place and up-to-date. By resolving potential issues beforehand, a mock PAI ensures smoother FDA interactions, reduces the risk of surprises during the real PAI, and supports a predictable timeline for product approval.
We find that mock PAIs often lead to improvements in quality systems, SOPs, data controls, and personnel training, all of which are critical to maintaining compliance for both approval and long-term operations.
When Launching New Products: A mock PAI is critical when launching a new product, especially one that involves a new or modified manufacturing process, facility, or supply chain.
After Major Changes: Significant organizational or operational changes, such as the installation of new equipment, a new manufacturing line, or changes to quality systems, should trigger a mock PAI to ensure continued compliance with FDA standards.
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.
Our drug-focused mock PAIs cover critical areas including, but not limited to:
Manufacturing processes and controls
Facility and equipment systems
Operational readiness
For medical device manufacturers, our mock PAI assessments include, but are not limited to:
Design controls and risk management
Manufacturing process validation
Quality system regulations (QSR) compliance (and QMSR compliance)
Software validation (if applicable)
Operational readiness
Our biologics-specific mock PAIs address unique considerations including, but not limited to:
Operational readiness
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.