4 Types of FDA Inspections You Must Know for Compliance

Inspections are the FDA’s way of asking: ‘Are you running a compliant company or just creating the illusion of one?’ For manufacturers in regulated industries, FDA inspections aren’t just another box to tick. They can shape everything from your product timelines to your market reputation. A single observation could delay shipments, lead to warning letters, or trigger broader investigations. According to FDA data, the agency issued over 3,000 Form 483 observations in fiscal year 2023, with pharmaceutical manufacturers receiving the highest number of observations related to data integrity and CAPA deficiencies For compliance managers, operational leaders, and QA heads, knowing the different types of FDA inspections is no longer optional,  it’s central to maintaining audit readiness and a risk-ready operation.

Here’s what manufacturers should know about the four key types of FDA inspections, how they differ, and how BPR hub can help your team to stay ahead of inspections .

What are FDA Inspections Looking For in Pharmaceutical Manufacturing?

The FDA doesn’t just inspect products. It evaluates systems, people, documentation, and compliance processes across your entire operation. Think of an inspection as a real-time test of whether your company is maintaining genuine audit readiness and upholding FDA regulations in daily practice not just on paper.

The scope of FDA oversight spans

• Pharmaceutical manufacturers (including APIs and biologics)
• Medical device facilities
• Food processing plants
• Cosmetics and dietary supplements
• Clinical research sites and labs

Depending on your industry, inspections may focus on different parts of your operations, but they all tie back to one thing: ensuring that public health is protected through consistent, compliant manufacturing.

Example: According to a reputable source, medical device manufacturers lose $26–$36 billion annually due to quality problems, with up to $3 billion in indirect costs from delayed launches, product withdrawals, and lost market share. These numbers highlight what's at stake every time an FDA inspector walks through the door.

FDA inspections in pharmaceuticals

It depends on your industry and product type, but in general, FDA inspectors are evaluating whether your operation aligns with applicable standards, whether that’s cGMP (21 CFR Parts 210/211), QSR (21 CFR Part 820), or other regulations.

If you’re in pharmaceuticals, they’ll be reviewing

• Batch manufacturing records
• Stability and FDA testing data
• Lab controls and validations
• Change controls and CAPA

If you're a medical device manufacturer, expect the FDA to dive into

• Design controls
• Risk management documentation
• Complaint files and MDR processes
• Device history and master records

No matter the inspection type, the FDA’s bottom line is simple: prove your product is safe, effective, and reliably made.

How the FDA Conducts Risk-Based Inspections

FDA has increasingly adopted a risk-based inspection strategy. This means inspections are driven not just by schedule, but by data.

Here’s what that looks like in practice

• CDER’s Site Selection Model uses algorithms to predict which drug manufacturing sites pose the highest potential risk to product quality.
• Medical device inspection priorities are set using tools like the Compliance Risk Indicator.
• Remote assessments and electronic records are now used in advance to triage which facilities require in-person visits.

The better your track record, the more likely you’ll be placed in a lower-risk category potentially reducing inspection frequency. But it cuts both ways: a single compliance lapse can move you to the top of the list.

What Are the 4 Main Types of FDA Inspections and Their Purposes?

There are 4 types of FDA inspection. Each inspection has a specific purpose and is triggered by different conditions. Let’s break down what triggers them, what they target, and how to prepare effectively using your FDA inspection checklist.

Pre-Approval Inspection (PAI)

A Pre-Approval Inspection happens after a company submits a new drug or device application, but before FDA grants marketing approval. The goal? Verify the accuracy of the application and ensure your facility is truly capable of manufacturing the product to spec.

What FDA checks during PAI

• Whether your manufacturing process is validated
• If you’ve followed proper protocols for stability and batch testing
• That your facility and team can meet the ongoing standards for quality

If gaps are found during this inspection, product approval may be delayed or denied altogether. Treat PAIs as the FDA’s way of saying: “Prove it before we trust it.”

Routine Surveillance Inspection

These are your standard FDA inspections, often scheduled every 1–3 years based on the risk profile of your facility. If your product is considered high-risk or you’ve had issues in the past, expect more frequent visits. Routine inspections test whether your everyday operations, not just your documentation, truly meet FDA standards. 

Expect inspectors to dig into the evidence behind your systems:

• Training records
• Batch records
• Complaint logs
• SOPs
• CAPA history

Having a solid FDA checklist for inspection can make these audits much smoother. The goal here is to show that your quality system works not just on paper, but in real-time.

For-Cause Inspection

A For-Cause Inspection is triggered by specific concerns: a whistleblower complaint, product recalls, a surge in adverse event reports, or a failure noted during a previous inspection.

Expect deep scrutiny here. Inspectors will often focus narrowly on the area of concern, but may expand scope if additional issues emerge.

Key focus areas

• CAPA effectiveness
• Root cause analysis and corrective action
• Potential patient safety impacts
• Management accountability

These inspections show up without warning—and they zero in on your riskiest gaps, from recent complaints to unresolved 483s.

Compliance Follow-Up Inspection

If your facility received a Form 483 or a Warning Letter, the FDA may conduct a follow-up to verify that corrective actions were completed and effective. This is essentially your second chance to demonstrate that the problems have been resolved.

FDA will assess

• Your corrective actions were completed
• You’ve made changes to prevent future violations
• That similar issues aren’t recurring

This inspection can determine whether enforcement action proceeds or whether your team has turned the corner.

Reduce your audit prep time by 40%—see how.

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How Do FDA Inspections Work?

FDA inspections follow a structured format,

Arrival and Credentials: Inspectors show identification and provide a Form 482 (“Notice of Inspection”).

Opening Discussion: They’ll explain the scope and objectives of the visit.

Facility Tour: Expect a walkthrough of key areas including labs, cleanrooms, storage, and manufacturing zones.

Document Review: Inspectors will request records—ranging from SOPs to validation reports to FDA testing results.

Interviews: Team members may be questioned on procedures, deviations, or their role in quality processes.

Daily Close-Outs: At the end of each day, the inspector may share informal feedback or observations.

Final Wrap-Up: If issues are found, the inspector will issue a Form 483 noting the observations.

All communications during an inspection should be clear, honest, and documented. It’s vital that your team knows who speaks, who provides documents, and how to escalate any confusion.

How Does the FDA Select Facilities to Inspect?

The FDA doesn’t rely on random selection. Facilities are prioritized based on risk models that incorporate several factors:

• Product type (sterile injectables and biologics get more attention)
• Compliance history (previous 483s, warning letters)
• Facility size and output volume
• Adverse event reports or recalls

Facilities can also be added to the list based on tip-offs, trade complaints, or regulatory changes.

This is why FDA audits aren’t a matter of “if” they’re a matter of “when.” And why compliance isn’t just about inspection day it’s about your everyday systems being solid.

Read more about→ How to Get FDA Approval: Process, Standards, and Benefits for Manufacturers

How BPRHub Helps with FDA Inspection 

BPRHub gives quality and compliance teams a single source of truth—so you’re not scrambling to find documents or explain deviations when the inspector arrives.

With BPRHub, you can:

• Access all SOPs, CAPAs, and batch records in one centralized system
• Track and manage multiple standards like FDA, ISO 13485, and 21 CFR Part 11
• Generate custom reports and audit trails in minutes—not hours
• Stay ahead of audits with built-in workflows, alerts, and compliance dashboards
• Reduce inspection prep time by up to 40% with a unified FDA checklist for inspection

Whether you're facing a pre-approval inspection, a for-cause visit, or a routine check, BPRHub helps you stay organized, inspection-ready, and confident every step of the way.

Contact BPR hub now to streamline your systems and drive real results with expert-led solutions.

📍 Book a Demo
📧 hello@bprhub.com

Key Takeaways

→ The types of FDA inspections each serve different purposes from approvals to routine checks to problem investigations.

→ Facilities in pharma and medical device inspection spaces face higher scrutiny under cGMP and QSR.

→ Inspection readiness depends on daily habits, not last-minute sprints.

→ Risk-based models now guide how often and why facilities are inspected.

→ A clear fda checklist for inspection, centralized data, and proactive training are your best tools for audit readiness.

→ With BPRHub, teams can confidently manage fda audits, compliance workflows, and multi-standard demands without scrambling.

FAQ

Q. What are the 3 main types of inspections?

The three core types are Pre-Approval, Routine Surveillance, and For-Cause inspections. Each serves a distinct purpose: approval readiness, general compliance, or issue investigation.

Q. What is a level 1 FDA inspection?

A Level 1 inspection typically refers to a targeted or for-cause audit. These are more focused and often shorter in duration, but may expand depending on findings.

Q. What are the most common findings of FDA inspections?

Common issues include inadequate CAPAs, incomplete batch records, data integrity problems, and failure to follow written procedures. Many stem from documentation gaps or missed reviews.

Q. What triggers an FDA inspection?

Triggers include new product applications (PAI), adverse event reports, prior violations, complaints, or routine schedules based on risk models.

Q. Does the FDA do unannounced inspections?

Yes. For-cause and some surveillance inspections can be unannounced. Facilities must be audit-ready at all times.

Q. What happens if you fail an FDA inspection?

You may receive a Form 483 or Warning Letter. Repeated or serious violations can lead to product holds, import alerts, or legal enforcement.

Q. How do I prepare for an FDA inspection?

Maintain accurate, accessible records. Train your team. Use a centralized system like BPRHub to manage standards, CAPA, and audit readiness workflows in real time.