WHY USE MOCK FDA INSPECTIONS?

What are mock FDA Inspections?

Mock FDA Inspections are a simulation, rehearsal, or practice setting that provides a projection of what might occur during the FDA inspection. It is an essential tool for medical device and pharmaceutical manufacturers. Therefore, your company’s executive-level management should support and participate during the opening and closing mock FDA audits.

Objectives

  • Strategize, plan, organize, and prepare for FDA inspections.
  • Identify non-compliant practices and correct them, if possible, before FDA inspections.
  • Practice each personnel member’s functions and roles during FDA inspections.
  • Confirm that your company’s current quality systems are in control.
  • Anticipate what FDA inspections might occur.
  • Prepare personnel technically and psychologically for FDA inspections.

Benefits of Using Our FDA Consultant:

  • Delivers the experience of our principal auditor. As an ex-FDA Investigator, Compliance Officer, and Supervisor Investigator, who has supervised medical device and drug investigators.
  • Specializes in Mock-Up FDA Inspections for medical device and pharmaceutical.
  • Provides unbiased insight and opinion.
  • Shares experiences and knowledge accumulated over 30 years of conducting both FDA inspections and mock FDA audits.
  • May coincidently and conveniently cover other standards and regulations such as European Medicines Agency, Medical Device Regulation (MDR), In Vitro Diagnostic Medical Devices (IVDR), Health Canada, Australian Therapeutic Goods Administration (TGA), and International Organization for Standardization (ISO).
Mock FDA Inspections

Prepare quality personnel technically and psychologically for FDA inspections.

FDA Consultant Travels

Our consultant can travel to you no matter where you are, but his schedule is filling up fast. Don’t wait until it’s too late. Schedule now for mock FDA inspections!

Our Procedure for Mock FDA Inspections

  • Duration 4-5 days
  • Follow current FDA inspection guidelines.
  • Meet and introduce company personnel.
  • Tour the facilities, interview personnel, and review records.
  • Hold exit meeting with company executive(s) to discuss major and minor findings and recommend changes.

Mock-up FDA audits are crucial in identifying and addressing the gaps in quality systems before the FDA Inspector’s arrival. It is not a complete fix, but it will demonstrate how to handle the events that might occur during an FDA inspection. After mock-up FDA audits, you are much better prepared for FDA Inspection.

Schedule Mock FDA Inspections

From pharmaceutical to medical device manufacturers must comply with the U.S. FDA laws and regulations have always found it challenging to go through inspections successfully. From taking a thorough look at your manufacturer’s current quality practices to finding helpful opinions, you need to schedule mock FDA inspections to ensure maximum compliance.

If that’s precisely what you have been thinking, then you have reached the right place.

We have been providing mock-up FDA audits to medical device and drug manufacturers.

We are veteran ex U.S. FDA investigators, and that’s precisely why we are confident to help you unlike any other.

If you have been actively looking for a team of ex U.S. FDA investigators, don’t wait anymore. Furthermore, we will engage all of our experience and skills in critically examining and determining your company’s compliance with the U.S. FDA laws and regulations.

You can schedule mock FDA audits with us today.

Not only have we acquired more than 30 years of experience in the field, but we have developed unique approaches, methodologies, and practices that help us a lot in delivering mock-up FDA audits. Manufacturers have continued to recommend us, and that’s one of the key elements allowing us to stand out.

By opting for our services and professional consultancy, you can make the most by engaging with us.

Our consultant follows the latest U.S. FDA inspection guidelines.

Our FDA Consultant will provide you with a detailed set of critical tips and suggestions. We will share our experience and provide you with unmatched guidance.