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June 3, 2021 Life Science Consulting

Preparing for an FDA Inspection, Part 1

James Meckstroth Associate Director, Clinical Services


The ultimate goal of the U.S. Food and Drug Administration is to protect the public welfare and protect consumers from unsafe products. Regulatory investigators are responsible for enforcing compliance to regulations. This enforcement is accomplished through on-site inspections designed to observe and evaluate a firm’s compliance with regulatory requirements.

If your firm manufactures FDA regulated products, you can expect periodic inspection visits. The nature of the inspection may vary:

  • Pre-Approval Inspection (PAI) – Requested and pre-scheduled. The PAI, can be narrowly focused on a specific product
  • Surveillance – Routine general system-based inspection of regulated facility
  • For-Cause – Inspection to investigate specific or potential problem

The scope of inspection may encompass a comprehensive evaluation of the facility and the facility’s procedures to confirm conformance with regulations. The inspection may be system-based or limited to a specific issue/area.

FDA Inspectors have broad authority with regard to conducting an inspection. They may enter the workplace anytime during business hours (presenting the firm with a FDA Form 482), speak with employees and management, and observe the operation of processes, instruments, and/or equipment. Additionally, they can require the firm to provide documents (and may retain copies), take photographs, collect samples (authorized by FDA Form 484), review historical electronic data, and inspect the contents of trash and recycling bins.

Q:      Why has the FDA been granted this broad power?

A:      Because GMP regulations are intended to ensure that human and animal products are safe and effective and otherwise in compliance with the federal, Food, Drug and Cosmetic Act (the Act). The Act was established to ensure Quality, Safety, Identity, Purity, and Strength of marketed food and drugs. FDA inspections are the government’s way of assuring the public that food and drugs comply with 21 CFR 210/211 GMP requirements. In support of that, FDA must assure accuracy and completeness of reported results, review evidence that procedures are followed, and ensure that your firm is in an overall state of control.

Anticipating an FDA inspection may seem intimidating, here are some tips on how you can ready your site:

  • Develop an inspection strategy: Have a suggested tour route, have a notification policy to alert appropriate internal colleagues of the inspection.
  • Have a prepared site overview presentation: It is useful to have high-level overview, including products produced, organizational chart, Quality System overview, types of equipment used, etc.
  • Have strong core quality systems: These will be evaluated (environmental monitoring, validation, laboratory, materials management, etc.). Anticipate what documents will be requested for these systems and have them readily available. Review older documents and determine if they are complete and still relevant.
  • Have a robust training program: Compliance against your own procedures will be scrutinized heavily.
  • Establish subject matter experts: Know who your “go to” inspection participants are. Inform them that in the event of an inspection that they will likely be asked questions or required to demonstrate a particular process.
  • Identify your site’s weaknesses and improve: Ensure that your self-inspections are meaningful, finding issues and improving your quality systems on your own is much easier than responding to 483 observations.

Understanding you firm’s quality system limitations and having a developed plan to improve will help ensure that you are prepared for your next regulatory inspection.

Stay tuned, Part II of this blog series discusses what to expect during an FDA inspection.

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