In 2025, the FDA has increased its for-cause inspections of Human Drugs and Biologics sites to almost 2.5 times its baseline¹.

This is a significant change, and one that is particularly impactful on the supply chains of Redica’s customers due to the increased risk of follow-on enforcement actions that result from for-cause inspection.

Thus, it is particularly important to understand for-cause inspections—including what triggers them, how Redica identifies those inspections for you, and how you can proactively address a for-cause inspection at one of your suppliers’ sites.

What is a for-cause Inspection?

The FDA initiates for-cause inspections based on a specific concern. FDA’s Types of FDA Inspections | FDA lays out this concept:

For-Cause Inspections: For-cause inspections are triggered when the agency has reason to believe that a facility has quality problems, to follow up on complaints, or to evaluate corrections that have been made to address previous violations.

Ultimately, there are five common triggers of for-cause inspections²:

Complaints (consumer, trade, or whistleblower)
Post-market safety signals (FARs, MDRs, MedWatch, or clinical findings)
Product quality or manufacturing issues (recalls, field alerts, or market withdrawals)
Regulatory history (prior 483s, warning letters, injunctions, or import alerts)
Enforcement referrals (from other FDA centers or agencies such as DOJ or DEA)

Each of these triggers can prompt the FDA’s Office of Inspections and Investigations or a product-specific center to assign a for-cause inspection. Sometimes, these inspections are combined with routine surveillance or pre-approval coverage, but their intent remains targeted: to determine whether a suspected compliance issue exists and how severe it is.

Redica’s goal is to standardize and simplify complex FDA data and drive quicker, more useful insights. Therefore, based on the above evidence, Redica designates an inspection as “for-cause” whenever it encounters any of the following inspection reasons, among others³:

For Cause
Consumer complaint
Follow-up to a prior Official Action Indicated (OAI) inspection
Follow-up to a Warning Letter
Follow-up to an injunction
Follow-up to a Class 1 recall
Mutual Recognition Agreement (MRA) request
Outbreak or enforcement response
Field Alert Reporting, MedWatch, and other post-market safety findings

Using this approach, Redica quickly identifies for its customers all of the inspection types that are the most likely to lead to further adverse outcomes like follow-up inspections, warning letters, and import alerts.

How often do for-cause inspections happen?

For-cause inspections typically make up around 10% of FDA Human Drugs and Biologics inspections⁴. However, as mentioned above, that has changed significantly in the past year, indicating a shift in approach by the FDA’s inspectorate and enforcement division.

The FDA is on track in 2025 for almost 25% of its inspections to be for-cause. In other words, sites in your supply chain are 2.5x more likely to receive a for-cause inspection than they were previously.

Why is this important?

Redica data shows that Human Drugs and Biologics sites that receive a for-cause inspection have a 33.5% chance of an Official Action Indicated (OAI) classification, which is 5.6 times higher than routine FDA inspections for the same sites⁵.

Because approximately half of OAIs lead to a Warning Letter or Import Alert issuance, for-cause inspections can no longer be seen as anomalies, but instead as a recurring feature of FDA oversight requiring active risk and supplier management.

How to proactively address a for-cause inspection

Redica enables customers to monitor their supply chain with Spaces, getting proactive notifications of new inspections, documents, and outcomes at their sites. By setting up this monitoring, customers can react quickly—often before a supplier even notifies them of an adverse inspection event.

If one of your sites or suppliers has been notified of an upcoming inspection, use our Inspection Intelligence tools to minimize the chances of adverse inspection outcomes.

Finally, for enterprise customers subscribed to our Site Intelligence Cloud, Redica analyzes both public and internal company signals to measure rising or falling risks across customers’ supply chains, allowing them to send experts and auditors to address problems before an inspection even occurs.

In all cases, Redica inspection data and analytics help uncover early warning signals, benchmark enforcement trends, and identify where inspection risk is rising—so teams can act before a compliance concern becomes a crisis.

Measured as an overall percentage of all Human Drug and Biologics inspections conducted in 2025, compared against each of the previous 5 years. From Redica’s analysis of FDA data.
One can find further evidence across several foundational documents, including 1) Investigations Operations Manual (IOM) (outlining how inspections are planned, conducted, and categorized), 2) Compliance Program 7356.002 (Drug Manufacturing Inspections) and 7382.845 (Medical Device Inspections) (product-specific criteria), and 3) Compliance Program 7346.832 (explaining how pre-approval and for-cause coverage can overlap).
Redica’s methodology maps inspection reasons obtained from both publicly available data and Redica’s tailored FDA information requests.
Human Drugs and Biologics FDA inspections conducted from 2020 through October 30, 2025, sourced from Redica Systems FDA data.
Human Drugs and Biologics GMP inspections conducted between January 2021 and October 2025 from Redica Systems’ FDA data.