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Thank you for contacting AP FDA Consulting regarding our global mock inspection services. We offer a realistic, simulated inspection environment led by a team that has spent decades serving as both FDA field agents and expert regulatory auditors.

Depending on your specific products and manufacturing operations, we typically recommend a three-to-five-day onsite inspection to ensure the process is as rigorous and realistic as possible. Our team utilizes the FDA’s current procedures and the Investigations Operations Manual (IOM) to conduct every mock audit. At the end of each day, we lead a comprehensive debrief to discuss any issues discovered that could potentially affect your quality system or regulatory compliance.

Remote Audit Services: Specialized Logistics Practice. In addition to our global onsite visits, we offer Remote Mock Audit services. While we recognize that a remote setting is not ideal and will not be as realistic as an onsite presence, it serves as an excellent practice tool for your team. Remote audits are particularly effective for pressure-testing your Front Room and Back Room dynamics, ensuring your staff can manage document requests and subject matter expert (SME) interviews seamlessly in a virtual environment.

The AP FDA Consulting Advantage: Unlike many career investigators, our team possesses a diverse and rare dual-perspective. Our background includes high-level roles within the U.S. FDA as:

• Laboratory Chemists

• Domestic and International Medical Device & Drug Investigators

• FDA Compliance Officers (Experienced in issuing Warning Letters)

• Field Managers

In addition to our agency tenures, we bring over 16 years of direct experience working within the pharmaceutical and medical device industries. This allows us to relate to both the FDA’s enforcement position and the industry’s operational challenges. We apply this “insider-outsider” strategy to every mock inspection under 21 CFR Parts 210, 211, 820, 360, and 4.

From our headquarters in California, we travel worldwide to ensure your facility is prepared for the real thing at reasonable costs. Time is of the essence—regulatory readiness cannot wait.

Contact Us Today to Schedule Your Onsite or Remote Mock Inspection!