A Step-by-Step Guide to Prep Your Clinical Research Lab for an FDA Inspection

Laboratory Software for Clinical Research Labs

The Food and Drug Administration (FDA) conducts regular inspections of regulated labs, such as clinical research labs, to ensure that they are complying with the pre-defined rules and regulations.

FDA inspection should be carried out every other year. It may be more frequent for new labs, those producing new FDA-regulated products, or those with a history of non-compliance. The inspection can be announced or unannounced.

As you will learn later in this blog, failing an FDA audit can have dire repercussions for a clinical research lab. Consequently, it is important to prepare adequately for this inspection. Is your lab ready?

Why Does the FDA Conduct Inspections?

The FDA Inspection is conducted to assess compliance with FDA regulations. In a clinical setup, the FDA may want to investigate whether the clinical researchers are carrying out studies in compliance with regulations such as obtaining informed consent and ensuring privacy of participants at all times.

It involves various processes, including the following:

  • Review of lab SOPs and other documents
  • Review of records
  • Inspection of the facility
  • Inspection of instruments

The FDA also conducts inspections for risk analysis. This is to determine whether a lab has implemented measures to assess and monitor risks and prevent them from happening.

The FDA may carry out an inspection to verify the authenticity and accuracy of data that has been submitted to them. For clinical labs, this may include the number of subjects that have been enrolled in a study.

Lastly, the FDA may carry out an inspection in response to a complaint raised by stakeholders or an ensuing public health concern. Such inspections are usually impromptu.

Types of FDA Inspection

There are four types of FDA Inspections:

  • FDA pre-approval inspection
  • Routine inspection
  • Compliance follow-up inspection
  • “For Cause” inspection

Pre-approval Inspection

This inspection is carried out once a lab submits an application to the FDA prior to conducting a new research or study. The lab is inspected to ensure that it is capable of performing the research or study. The inspectors will either recommend or fail to recommend the lab for FDA approval.

Routine Inspection

This inspection is carried out routinely once every two years.

Compliance Follow-up Inspection

This inspection is carried out following a previous inspection where a lab failed to meet the expectations of the inspectors. When this happens, the lab is issued with a warning letter or a 483 observation and a follow-up is necessary to confirm that appropriate remediation measures have been put in place.

“For-cause” Inspection

This is carried out to investigate a specific issue that had been raised by the FDA. It usually focuses on one key issue; however, other issues may arise during the inspection.

The Bioresearch Monitoring (BIMO) program conducts on-site inspections, audits, and compliance assessments for FDA-regulated research. This includes verifying the integrity of data submitted for new drug approvals and food products. BIMO safeguards the interests of both the FDA and the subjects enrolled in clinical studies.

Steps to Prepare for an FDA Inspection

All kinds of inspections require adequate preparation, unless it’s an impromptu one. Pre-approval inspections will determine whether you get FDA approval or not. Failing this inspection will mean that all the time and resources that had been invested into the project went down the drain. It’s therefore important to prepare adequately for this inspection.

Here are a few critical steps that should be taken prior to an FDA Inspection:

1. Determine the Nature of the Inspection

Once you are aware that there’s an upcoming FDA inspection, you need to determine the nature of the inspection and what will be required. Routine inspections are usually scheduled 10 working days in advance and once scheduled, they are not easily postponed.

2. Identify Operational Gaps

Once you have established the nature of the inspection, you should identify any operational gaps that may be pointed out during the inspection and address them.

3. Prepare Your Team for the Inspection

Let staff participating in the inspection know in advance what will be required of them and how to prepare. Let them familiarize themselves with questions that may be asked including where to find documents and records that may be requested of them.

4. Review Records and Documents

Most inspections will involve the reviewing of documents and records. Go through such things to ensure that they are current, accurate, and up-to-date.

5. Create Space for the Inspectors

The inspectors may need a room to put their supplies or conduct their meetings. Make sure that this is available.

6. Put Together an Inspection Readiness (IR) Team

Routine inspections do not happen regularly and should therefore not catch you by surprise.

Your lab should always have an IR team whose role is to ensure that the lab is always ready for an inspection. Should an impromptu inspection come up, this team will be able to save the day.

7. Conduct a Mock Inspection

You may find that in spite of all the preparation, your team members might still feel unprepared. It is advisable to conduct a mock inspection or an internal audit to walk your staff through all the steps of the inspection. Have an external team audit all the documents and records and give objective feedback.

Preparing for an FDA inspection should be an ongoing practice, in other words, your lab should always be prepared for an inspection and hence, ensure that the highest standards are maintained. Failing an FDA inspection will have some repercussions that are better avoided.

What are the Penalties for not Meeting FDA Inspection Requirements?

Should a lab fail to meet the inspection standards, the inspecting team will issue an FDA 483 form. A warning letter will be issued in case the FDA determines that the violation is severe.

How a Laboratory Software for Clinical Research Labs Can Help Prep for an FDA Inspection

An FDA inspection can be intimidating, especially when you are not adequately prepared and are unaware of the process. Did you know that a Laboratory Information Management System (LIMS) can make this process much easier?

laboratory software for clinical research labs, also known as clinical LIMS, helps manage samples and their associated metadata effectively. It also automates workflows or SOPs, assures end-to-end traceability, and in the process, increases efficiency and minimizes errors. It helps securely manage patient data and electronic informed consent (eConsent) of patients. Furthermore, it helps manage studies, documents, and staff training, and assigns role-based data access to authorized users. This ultimately supports the lab’s compliance with regulatory and quality management requirements.


The FDA conducts regular inspections of regulated labs such as clinical labs. The aim is to ensure compliance with regulatory requirements and to confirm that appropriate measures are in place to avert risks. The FDA also inspects new labs before approving them.

When labs “fail” the inspection, they may be compelled to pay hefty fines, and they also risk losing their licenses. Consequently, labs need to prepare adequately for both scheduled and impromptu FDA inspections.

A laboratory software for clinical research labs can assure efficient quality management and help prepare for FDA inspections by automating processes that support compliance.

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