Can FDA Inspect Outside the US? (w/Examples) + FAQs

Yes, the U.S. Food and Drug Administration (FDA) can—and does—inspect facilities outside the United States. The agency conducts approximately 3,000 foreign inspections annually across more than 90 countries to ensure products entering the American market meet federal safety standards.

This authority stems from Section 704 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the agency’s power to regulate imported products under 21 U.S.C. § 381. Foreign manufacturers face a stark reality: in FY 2024, more than 62% of all drug quality assurance inspections occurred at foreign sites—an all-time high. The FDA issued 105 warning letters for quality issues that same year, the highest number in five years.

In this article, you will learn:

🏭 How FDA’s foreign inspection authority works and which laws give the agency its power

⚖️ The three types of inspections (pre-approval, routine surveillance, and for-cause) and what triggers each one

🌍 Real examples of companies that faced severe penalties for inspection violations or refusal

📋 Common mistakes foreign manufacturers make that lead to import bans and warning letters

✅ Step-by-step actions to prepare for—and recover from—an FDA foreign inspection

How FDA Gets Authority to Inspect Foreign Facilities

The FDA does not have direct extraterritorial inspection authority in the traditional sense. Instead, the agency relies on its power to regulate imported products and the voluntary cooperation of foreign firms that want access to the U.S. market.

Here is how this works in practice. Under 21 U.S.C. § 381, the FDA has authority over products offered for import into the United States. If a foreign manufacturer wants to sell drugs, medical devices, food, cosmetics, or other regulated products in America, that manufacturer must allow FDA inspections. The consequence for refusal is clear: products get blocked at the border.

The FD&C Act defines “interstate commerce” to include commerce between any State or Territory and any place outside thereof. This broad definition gives FDA jurisdiction over foreign manufacturers whose products enter U.S. commerce.

The Legal Framework in Plain Terms

Foreign manufacturers should understand a critical point: the FDA cannot force entry into a foreign facility the way it can enter a domestic facility. However, the agency has powerful indirect mechanisms to ensure compliance. If a firm refuses to allow—or significantly delays—an FDA inspection, the agency can refuse entry of that firm’s products into the U.S. market.

What Products Does FDA Inspect Abroad?

The FDA inspects foreign facilities that manufacture, process, pack, or hold any product under its jurisdiction. This includes:

Pharmaceuticals and Biologics: Both finished drugs and Active Pharmaceutical Ingredients (APIs) fall under FDA oversight. For drugs, the agency verifies compliance with Current Good Manufacturing Practice (CGMP) requirements under 21 CFR Parts 210 and 211. For biologics like vaccines, blood products, and gene therapies, 21 CFR Part 600 governs manufacturing requirements. A manufacturer cannot distribute a biological drug in the U.S. until it has passed a facility inspection and received FDA licensure.

Medical Devices: Device manufacturers must comply with the Quality System Regulation (QSR) under 21 CFR Part 820. Foreign device inspections typically follow Level 2 (Comprehensive) protocols under Compliance Program 7382.845.

Food Products: The Food Safety Modernization Act requires FDA to increase foreign food facility inspections and to double those inspections each year for five years. The agency inspects food processors, packers, repackers, and holders of foods under FDA jurisdiction.

Cosmetics: Under Section 704 of the FD&C Act, FDA has legal authority to inspect cosmetic establishments and cosmetics offered for import. Investigators look for prohibited ingredients, microbial contamination, and labeling deficiencies.

Tobacco Products: Foreign tobacco manufacturers must comply with premarket authorization requirements for products not already marketed before February 15, 2007. The FDA conducts pre-approval inspections as part of the PMTA (Premarket Tobacco Product Application) evaluation process.

Human Cells, Tissues, and Cellular/Tissue-Based Products (HCT/Ps): The FDA inspects facilities under 21 CFR Part 1271 to protect consumers from unsafe tissue-based products.

Three Types of FDA Foreign Inspections

Foreign manufacturers encounter three main inspection types. Each serves a different purpose and carries different implications.

Pre-Approval Inspections (PAI) / Pre-License Inspections (PLI)

These inspections occur before FDA approves a product application. For drugs, the agency conducts PAIs to support New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs). For biologics, Pre-License Inspections (PLIs) verify that facilities can manufacture products as described in Biologics License Applications (BLAs).

The purpose is clear: FDA wants to verify that manufacturing operations conform to CGMP requirements and that data submitted in the application are accurate and complete. Manufacturers should expect these inspections because the agency gives reasonable notice during the application review timeline.

Routine Surveillance Inspections

These inspections monitor ongoing compliance at facilities already manufacturing products for the U.S. market. The FDA uses a risk-based schedule to determine which facilities to inspect and when. Factors include:

• Facilities with limited inspection history
• Sites with known quality issues or product recalls
• Manufacturers in countries with low regulatory transparency

Historically, foreign surveillance inspections were pre-announced due to diplomatic protocols and logistics. That practice is changing. In May 2025, FDA announced plans to expand unannounced inspections at foreign facilities to ensure parity with domestic oversight.

For-Cause Inspections

These inspections respond to specific concerns. Triggers include:

• Consumer or trade complaints
• Adverse event reports
• Product recalls
• Intelligence suggesting fraud or data integrity problems
• Whistleblower allegations

For-cause inspections can happen at any time with little or no warning. The FDA prioritizes these based on risk to public health.

The Shift to Unannounced Foreign Inspections

For decades, foreign manufacturers enjoyed what FDA Commissioner Martin Makary called a “double standard”—they received weeks of advance notice before inspections while U.S. manufacturers faced unannounced visits. That era is ending.

On May 6, 2025, FDA announced its intent to expand unannounced inspections at foreign manufacturing facilities. The agency had already piloted this approach in India and China. By May 2024, FDA had conducted 114 pilot inspections in India (94 unannounced) and 28 in China (16 unannounced).

The rationale is simple: advance notice allows bad actors to hide violations. In FY 2024, 45% of foreign inspections revealed data integrity concerns or failure to meet basic CGMP standards. Despite receiving advance warning, foreign firms showed serious deficiencies more than twice as often as domestic facilities.

The policy shift also includes new ethics requirements. FDA inspectors will no longer accept travel accommodations from regulated industry—no lodging, transportation, or other arrangements that could compromise oversight integrity.

Country-by-Country Inspection Data

Not all regions face equal scrutiny. The FDA focuses inspection resources on countries with high manufacturing volumes and compliance concerns.

India

India is a major source of generic drugs and APIs for the U.S. market. In FY 2024, 34% of sites in FDA’s Site Catalog were inspected. Indian manufacturers had the highest rate of serious CGMP violations at 13%. Only 87% of Indian inspections received NAI or VAI classifications—the lowest rate among major manufacturing regions.

China

Chinese facilities saw a sharp increase in inspections in FY 2024—227 inspections compared to 61 in FY 2023 and just 8 in FY 2022. Of all facilities issued import alerts globally, 39% were located in China compared to the 10% average for other regions.

Europe

European manufacturers benefit from the U.S.-EU Mutual Recognition Agreement (MRA). Under this agreement, FDA and EU regulatory authorities share inspection reports and GMP surveillance information. European firms achieved a 98% NAI or VAI classification rate—the highest globally. However, both FDA and EU reserve the right to inspect at any time in each other’s territory.

Real-World Examples of FDA Foreign Enforcement

Understanding enforcement actions helps manufacturers grasp the stakes. Here are documented cases that illustrate consequences.

Ranbaxy: $500 Million Settlement (2013)

Indian generic drug manufacturer Ranbaxy USA Inc. pleaded guilty to three felony FD&C Act counts and four felony counts of making false statements to FDA. The violations included:

• Failing to conduct proper safety tests for drugs like gabapentin and ciprofloxacin
• Falsifying stability testing data to suggest compliance

Ranbaxy paid $150 million in criminal fines and forfeitures plus $350 million to settle civil claims under the False Claims Act.

Fresenius Kabi Oncology: $50 Million (2021)

Indian drug manufacturer Fresenius Kabi Oncology Limited (FKOL) pleaded guilty to concealing and destroying records before a 2013 FDA inspection of its Kalyani, West Bengal facility. According to court documents, company management directed employees to:

• Remove records from premises before the inspection
• Delete records from computers
• Blend failed ingredient batches with passing batches

FKOL paid $30 million in fines and forfeited $20 million.

Chinese Testing Laboratories: Data Integrity Failures (2024-2025)

FDA issued warning letters to two Chinese nonclinical testing laboratories—Mid-Link Testing Company Ltd. and Sanitation & Environmental Technology Institute of Soochow University Ltd.—citing laboratory oversight failures and animal care violations. FDA then took further action after discovering falsified data. Commissioner Makary stated: “The FDA has no room for bad actors. Once we discover data integrity issues, we will respond accordingly.”

Tyche Industries Ltd.: Import Alert (2025)

Indian company Tyche Industries Ltd. received a warning letter in February 2025 following an August 2024 inspection. The FDA found insufficient documentation practices and placed the company on import alert. The agency may refuse new applications or supplements listing the company as manufacturer until the site addresses all observations.

What Happens During a Foreign Inspection

Understanding the inspection process helps manufacturers prepare. Here is the typical sequence:

Scheduling

FDA is not required to announce foreign facility inspections. However, the agency’s general practice (which is now changing) has been to contact firms to facilitate the process. FDA coordinates with both the establishment and the host government, first sending a written request to the government on its intent to inspect facilities in that country.

The Inspection

The FDA investigator presents credentials and a written notice of inspection (Form FDA 482) to the most responsible individual present. The investigator then:

• Observes areas where regulated products are manufactured, processed, packed, or held
• Reviews records as authorized by law
• Takes photographs
• Collects samples (environmental, finished product, raw material, in-process material)

Foreign government representatives may accompany the FDA investigator during the inspection.

Documentation Requests

Reasonable delays to records requests are generally accepted if a good-faith effort is made to comply. However, unreasonable delays constitute refusal. The investigator documents observations on Form FDA 483, which lists conditions the investigator believes may violate FDA regulations.

Post-Inspection

If the investigator found objectionable conditions, the firm receives a Form 483 at the inspection’s close. The firm should respond within 15 business days addressing each observation. A strong response can help avoid warning letters, product approval delays, or plant shutdowns.

What Constitutes “Refusal” of Inspection

The FDA defines refusal broadly. Under Section 807(b) of the FD&C Act, an owner, operator, or agent in charge is considered to have refused inspection if they do not permit an inspection within 24 hours of receiving FDA’s written request.

The agency also considers “statements, actions, and passive behaviors” that prevent or delay scheduling or fully conducting an inspection to be refusals.

A foreign government’s refusal to allow FDA entry into the country or inspection of a facility also triggers consequences for that facility—even though the facility cannot control its government’s actions.

Consequences of Refusing or Failing FDA Inspection

The consequences escalate based on severity and compliance history.

Form FDA 483 (Inspectional Observations)

This is not a finding of violation—it lists observations the investigator believes may violate regulations. However, failing to respond adequately often leads to warning letters.

Warning Letters

Warning letters notify firms of significant violations and request corrective action. In FY 2024, FDA issued 105 warning letters for quality issues—the highest in five years. China, India, and South Korea were the leaders in quality-related warning letters.

Import Alerts

Import alerts inform FDA field staff that the agency has enough evidence to permit Detention Without Physical Examination (DWPE) of products that appear violative. Key import alerts for foreign manufacturers include:

• Import Alert 99-32: Products from foreign establishments refusing FDA inspection
• Import Alert 66-40: Drugs from firms not meeting CGMP requirements
• Import Alert 66-79: Drugs from establishments refusing FDA inspection

Being placed on an import alert’s “Red List” means your products face automatic detention at U.S. borders.

Criminal Prosecution

For egregious violations—especially data falsification, fraud, or obstruction—the Department of Justice can pursue criminal charges. As the Ranbaxy and Fresenius Kabi cases show, fines can reach hundreds of millions of dollars. Criminal liability can also attach to individual executives.

Inspection Classification System

FDA classifies inspections based on findings. Understanding these classifications helps gauge your compliance status.

No Action Indicated (NAI)

This is the best outcome. It means no objectionable conditions or practices were found. The facility is considered in compliance.

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but they do not rise to the level of enforcement action. The FDA expects the company to take corrective actions voluntarily. Most firms should treat VAI as a warning that requires immediate attention.

Official Action Indicated (OAI)

Regulatory and/or administrative actions are recommended. This classification often leads to warning letters, import alerts, injunctions, or other formal enforcement. OAI means the firm has serious problems requiring immediate corrective action.

Remote Regulatory Assessments (RRAs)

During the COVID-19 pandemic, FDA developed Remote Regulatory Assessments to examine facilities remotely when travel was restricted. These tools have become permanent.

RRAs may include:

• Remote records requests
• Remote livestreaming video of operations
• Teleconferences
• Screen sharing

FDA does not consider RRAs to be inspections. The agency does not issue Form 482 (Notice of Inspection) before an RRA or Form 483 after one. However, RRAs can identify issues that lead FDA to conduct on-site inspections or take regulatory action.

Participation in voluntary RRAs is optional, but declining may delay application decisions.

Mutual Recognition Agreements

The FDA shares inspection information with certain trusted foreign regulatory authorities under Mutual Recognition Agreements (MRAs).

U.S.-EU MRA

The U.S.-EU MRA became fully operational for GMP inspections on July 12, 2019. Under this agreement:

• FDA and EU authorities share GMP surveillance inspection reports
• Both parties may rely on each other’s inspections
• Duplicate inspections are reduced

Both FDA and EU reserve the right to inspect in each other’s territory at any time. In October 2025, the EMA announced it would begin voluntarily relying on FDA inspections of manufacturing sites outside the U.S.

Mistakes to Avoid During Foreign Inspections

Learning from others’ failures prevents costly errors. Here are common mistakes and their consequences:

Not responding to FDA’s scheduling request within 24 hours: This alone constitutes refusal and can result in immediate placement on Import Alert 99-32 with all products blocked at the border.

Hiding or destroying records before inspection: Fresenius Kabi’s $50 million penalty proves that FDA and DOJ actively prosecute obstruction. Modern forensic techniques can detect deleted files.

Limiting investigator access to areas or records: Partial access is considered refusal. Investigators document any attempt to restrict their movement or document review.

Stopping production during inspection without explanation: This signals to investigators that you are hiding normal practices. Continue normal operations.

Failing to respond to Form 483 observations: Companies have 15 business days to respond. Non-response increases the likelihood of a warning letter.

Using poorly trained interpreters: Miscommunication during inspections creates unnecessary problems. Use interpreters who understand both languages and technical terminology.

Assuming inspection won’t happen soon: With unannounced inspections expanding, facilities must maintain 24/7 inspection readiness.

Do’s and Don’ts for Foreign Manufacturers

Do’s

✅ Respond to FDA inspection requests within 24 hours — Under the FD&C Act, failure to respond within this window constitutes refusal.

✅ Maintain inspection-ready status at all times — With the shift to unannounced inspections, you cannot stage compliance for scheduled audits.

✅ Train employees on inspection protocols — Everyone from production workers to executives should know their roles during inspections.

✅ Conduct regular internal audits and mock inspections — Identify and fix problems before FDA finds them. Periodic mock inspections that mimic FDA protocols prepare your team.

✅ Document everything meticulously — Strong data integrity practices protect you. If it’s not documented, it didn’t happen.

✅ Respond to Form 483 observations thoroughly and promptly — Address each observation individually with specific corrective actions and timelines.

Don’ts

❌ Don’t refuse entry or access — This triggers immediate import alert placement and blocks all your products from entering the U.S.

❌ Don’t accept inspection dates and then request changes without valid reasons — FDA considers this obstructive behavior indicating potential concealment.

❌ Don’t make investigators wait unreasonably — Delays signal you have something to hide.

❌ Don’t provide incomplete records — Partial disclosure is as bad as non-disclosure.

❌ Don’t blame problems on language barriers — Get qualified interpreters. FDA Form 483 observations are written in English regardless of local language.

❌ Don’t offer travel accommodations to FDA investigators — Inspectors are now prohibited from accepting lodging or transportation from regulated industry.

How to Get Removed from an Import Alert

Being placed on FDA’s Red List is not permanent. Removal requires proving that the violation is fixed and prevented from recurring.

Step 1: Review the Import Alert

Identify the original violation and the specific requirements in the “Guidance” section of the import alert.

Step 2: Conduct Root Cause Analysis

Determine how the violation occurred. Document the investigation thoroughly.

Step 3: Implement Corrective Actions

Fix the immediate problem and implement preventive measures to stop recurrence. Update Food Safety Plans, HACCP plans, or GMPs as needed.

Step 4: Submit Five Clean Shipments

Most petitions require evidence of five consecutive, commercial-size, non-violative shipments tested by a third-party laboratory using FDA-accepted methods.

Step 5: Submit Formal Petition

Email your petition to the address on the specific import alert. Include all required documentation in FDA’s expected format.

FDA will issue a letter accepting or denying the petition. If denied, the agency explains what was missing so you can revise and resubmit. If any shipment is violative during review, the petition is denied and the process starts over.

The Foreign Supplier Verification Program (FSVP)

U.S. importers bear responsibility for their foreign suppliers under the FSVP regulation.

Importer Responsibilities

Importers must:

• Determine known or reasonably foreseeable hazards with each food
• Evaluate risk based on hazard analysis and foreign supplier performance
• Approve suppliers and determine appropriate verification activities
• Conduct supplier verification activities
• Conduct corrective actions when problems arise

For hazards with serious health consequences (SAHCODHA hazards), annual on-site audits of the foreign supplier are generally required.

Enforcement Examples

FDA has issued warning letters to multiple importers for FSVP failures. Talla Imports LLC received a warning letter for failing to develop any FSVP for imported foods including chocolate, cookies, and candy from Sweden. Premium Fresh Growers LLC was warned for importing limes, cilantro, and carrots without an FSVP—especially concerning for fresh produce that poses high contamination risk.

Preparing for Your Next FDA Inspection

Preparation separates compliant facilities from those facing enforcement.

Build an Inspection Readiness Team

Assign a Project Manager and Subject Matter Experts for each area that may be inspected. Include Quality team members who will lead the inspection response.

Conduct Gap Analysis

Identify the potential scope of inspection and compare current state to requirements. Create prioritized task lists and timelines.

Prepare Key Documents

Have these ready for immediate access:

• Organization chart (down to Operator or Analyst level)
• Site Master File
• SOP Master Index
• List of products
• Training procedures
• Recall procedures
• List of deviations, change controls, OOS results, complaints, and CAPAs since last inspection

Define Roles

Determine who will be in the front room interacting with investigators and who will be in the back room supporting with document retrieval and research.

Practice

Conduct mock inspections that mimic FDA protocols. Train cross-functional teams on inspection conduct, documentation, and escalation processes.

FAQs

Can FDA inspect a facility in any country?
Yes. FDA conducts inspections in more than 90 countries. However, the agency must coordinate with host governments and cannot force entry without consent.

Does refusing inspection protect a company from FDA penalties?
No. Refusal triggers immediate placement on import alert, blocking all products from entering the U.S. market.

Can FDA conduct unannounced inspections at foreign facilities?
Yes. As of May 2025, FDA expanded unannounced inspections to foreign facilities, bringing them under the same scrutiny as domestic sites.

Does a Form 483 mean FDA found violations?
No. Form 483 lists observations that may constitute violations. It is not a final agency determination of non-compliance.

Can a company appeal FDA warning letters?
Yes. Manufacturers may challenge findings by presenting factual counter-evidence and legal argument, especially if they believe FDA’s interpretations are inconsistent with law.

How long does FDA Red List removal take?
Months to years. The process requires root cause analysis, corrective actions, five consecutive clean shipments, and FDA petition review.

Must foreign facilities register with FDA?
Yes. Foreign food, drug, and device facilities exporting to the U.S. must register. For food, re-registration occurs every two years.

Can FDA prosecute foreign companies criminally?
Yes. Companies selling products in the U.S. submit to U.S. jurisdiction. DOJ has secured criminal convictions against foreign manufacturers for FDCA violations.

Does the EU-US MRA eliminate FDA inspections in Europe?
No. Both FDA and EU reserve the right to inspect at any time. Surveillance inspections may be reduced, but inspections remain possible.

What triggers a for-cause inspection?
Complaints, recalls, adverse events, intelligence, or whistleblower allegations. For-cause inspections respond to specific concerns about safety or compliance.

Can FDA inspect cosmetic facilities abroad?
Yes. Section 704 of the FD&C Act authorizes inspection of cosmetic establishments. Non-compliant imports may be refused entry.

Is 24 hours really enough time to respond to an inspection request?
Yes. Under Section 807(b), failure to respond within 24 hours after receiving FDA’s written request constitutes refusal.

Can I be removed from import alert for only some products?
Yes. FDA may grant product-specific removal while keeping other products from the same facility on the Red List.

What is the “Green List”?
An exemption list. Companies on a Green List have proven they should not be subject to an import alert that applies to their country or product type.