FDA Inspections
FDA Foreign Facility Inspection
If you manufacture devices outside the US for the US market, FDA can inspect your facility against the same requirements it applies at home. The logistics differ (travel, interpretation, scheduling) and the notice you get may differ too, so readiness has to hold up even when warning is short.
At a Glance
- Conducted by
- FDA investigators
- Applies to
- Foreign establishments that manufacture devices for the US market
- Requirements
- The QMSR and other FDA device requirements, as for domestic firms
- Notice
- Can differ from domestic practice and may change; plan for short notice
- Possible outcome
- Observations on Form 483; NAI, VAI or OAI classification
What It Is
Foreign establishments that make devices for the US market register with FDA, list their devices and name a US agent, and they are subject to the same QMSR requirements as domestic manufacturers. FDA inspects them to verify that, with the same expectations it brings to a US site.
What differs is logistics. Investigators travel, interpreters may be involved, and records kept in another language need to be understood. Notice practices for foreign inspections differ from the roughly five days' notice typical at domestic sites, and they can change, so a facility should be ready on short notice rather than counting on a long runway.
Time on site is finite, so a well-run inspection depends on fast retrieval and clear answers. Delays caused by missing translations or unavailable staff take time away from substance and leave a poor impression.
Who Conducts It
FDA investigators conduct foreign inspections. Some travel from the US, and FDA also maintains offices abroad.
Your US agent is a communication link FDA uses, so make sure they can reach the right people at the site quickly. On site, the same front room and back room roles apply, plus interpreters who understand quality system vocabulary.
What Triggers It
- Registration of a foreign establishment that manufactures devices for the US market
- FDA's routine, risk-based surveillance of foreign manufacturers
- A PMA that names the foreign site as a manufacturing location
- Complaints, MDRs or recalls that raise questions about the site's products
- Follow-up on findings from an earlier inspection
What They Look At
The Same Quality System Expectations
Risk management, the six QMS areas and the four other FDA requirements, applied as they would be at a domestic site.
FDA-Specific Requirements
Items that ISO 13485 certification alone may not cover: MDR, corrections and removals, UDI, complaint and servicing records under 820.35, and labeling controls under 820.45.
Records the Investigator Can Read
Whether key records are available in English or can be translated accurately and quickly without changing their meaning.
Registration and Listing Accuracy
Whether the site's registration, device listings and US agent information match what it actually makes and ships.
Control of US-Specific Labeling
US labeling, UDI and packaging kept under control where they differ from labeling for other markets.
Supplier and Outsourcing Controls
Oversight of local suppliers and subcontractors whose work affects US product.
How to Prepare
- 01
Plan for Short Notice
Keep an inspection procedure, a contact tree and a named host ready year-round rather than waiting for a scheduling call.
- 02
Translate the Core Records
Prepare controlled English versions or summaries of the quality manual, key procedures and the records most likely to be requested.
- 03
Arrange Qualified Interpreters
Line up interpreters who know quality and device terminology, and brief them on how inspections run and why precision matters.
- 04
Close the FDA-Specific Gaps
Check MDR, corrections and removals, UDI and US labeling controls, which a quality system built for other markets may handle loosely.
- 05
Confirm Registration and US Agent Details
Make sure registration, listing and US agent information is current and that the agent can reach the site quickly.
- 06
Practice Through Interpretation
Rehearse interviews through an interpreter so experts get used to short, precise answers that translate cleanly.
Common Pitfalls
- Assuming an ISO 13485 certificate or MDSAP report means the site is ready for FDA-specific requirements.
- Key records available only in the local language, with no controlled English version.
- Interpreters who paraphrase or add explanation, changing what the expert actually said.
- No one on site who knows how MDR and correction and removal decisions are made for US product.
- Outdated registration, listing or US agent information.
How QMSAdvisor Helps
- A document library that accepts what the site already has, in any format, so an AI-assisted first pass can run without migrating your system.
- Advisor-reviewed findings focused on FDA-specific requirements that a quality system built for other markets may miss.
- FDA Inspection Simulator sessions that rehearse document requests and interviews with the people who will face the investigator.
- A shared action plan where site and US teams see the same findings, owners and due dates.
FDA Inspection Readiness (CP 7382.850)
FDA device inspection preparation built around Compliance Program 7382.850 and its risk-based approach.
MDSAP Readiness
Prepare for one audit covering ISO 13485 and the country-specific requirements of participating regulators.
Mock FDA Inspection
A practice FDA inspection in our Inspection Simulator, with an advisor playing the investigator.
QMSR Transition
Bringing a QSR-era or ISO 13485 quality system in line with FDA's QMSR, which is now in effect.
Standards and Regulations Involved
Questions About the FDA Foreign Facility Inspection
How much notice will we get before a foreign inspection?
It varies. Notice practices for foreign inspections can differ from domestic ones and can change, so don't plan around a particular lead time. Be ready to host an inspection on short notice.
Do foreign sites follow the same rules as US sites?
Yes. Foreign manufacturers of devices for the US market are subject to the QMSR just as domestic ones are, along with MDR, corrections and removals, UDI, and registration and listing requirements as they apply.
Does MDSAP participation cover us?
FDA accepts MDSAP audit reports in place of routine surveillance inspections. It does not replace for-cause or pre-approval inspections, so stay ready for those.
Do all our records need to be in English?
The investigator needs to understand the records they review. Have English versions or reliable translations of key procedures and records, and be ready to translate others accurately on request.
Related Audits and Inspections
FDA Baseline Surveillance Inspection
FDA's comprehensive surveillance inspection of your quality system under Compliance Program 7382.850.
MDSAP Audit
One audit by a recognized auditing organization that covers several participating regulators, including FDA.
Remote and Hybrid Audits
Audits and regulatory assessments run partly or fully through video, screen sharing and electronic records.
Request an Assessment
Prepare for Your FDA Foreign Facility Inspection With an Advisor
Tell us what's coming and when, and an advisor will scope readiness work around it. Please don't send confidential documents yet: secure upload is set up after onboarding.
