FDA Inspections in 2026: Types and Readiness Plan

FDA inspection or FDA audit?

People often search for an “FDA audit,” but FDA’s own term is inspection: “a careful, critical, official onsite examination of a facility” to determine compliance with laws FDA administers (FDA). The difference matters. An audit by a certification body checks conformity to a standard you chose; an FDA inspection is a legal process that can lead to a Form 483, a warning letter or enforcement.

For how FDA inspects medical device makers under the QMSR, see FDA Medical Device Inspections in 2026: What to Expect Under QMSR.

Types of FDA inspections

Type	Purpose (FDA’s description)
Pre-approval (application-based)	Support review of an application; conducted “for about 20% of the application reviews conducted by the agency”
Surveillance	”Monitor the manufacturing process and the quality of FDA regulated products on the market”
For-cause	”Triggered when the agency has reason to believe that a facility has quality problems”
Follow-up	”Verify compliance and/or corrective actions in the wake of previous violative inspections”

Source: FDA, Types of FDA Inspections.

FDA also uses remote regulatory assessments (RRAs), finalized in guidance in June 2025. Ropes & Gray notes that “FDA does not consider RRAs to be inspections,” and no Form 483 is issued after one (Ropes & Gray).

How FDA inspections changed in 2025 and 2026

More of them. FDA says it conducted “more than 17,000 domestic and international inspections” in FY2025 (FDA Voices).

More unannounced, especially abroad. In May 2025, Commissioner Makary announced expanded unannounced foreign inspections: “For too long, foreign companies have enjoyed a double standard… That ends today” (FDA). FDA reports that the unannounced share of inspections in India rose from 47% in FY2025 to 87% in FY2026 year to date, and in China from 19% to 61% (FDA Voices).

Data-driven targeting. FDA’s Elsa AI tool is used to “identify high-priority inspection targets” (FDA).

New formats. In May 2026, FDA launched one-day inspectional assessments. Makary said they “can strengthen our inspectional approach by focusing our time and resources where they are most needed” (FDA).

New device inspection method. Since February 2, 2026, device inspections follow Compliance Program 7382.850 under the QMSR instead of QSIT, and investigators can review internal audit and management review records (FDA QMSR FAQ).

Not every trend points up. Reporting on a ProPublica analysis found foreign food inspections ran “nearly 30 percent lower” through July 2025 after staffing cuts (Food Safety Magazine). Frequency varies by program; readiness should not.

What happens during an FDA inspection

Arrival and credentials. Investigators present credentials and a Form 482, Notice of Inspection.
Opening discussion. Scope, key contacts and logistics.
Facility tour and document requests. Investigators follow FDA’s Investigations Operations Manual, the “primary operational reference for FDA investigators” (FDA).
Interviews and record review. Typically complaints, deviations, CAPA, batch or device history records, training and data systems.
Daily wrap-ups. Clarify questions and correct misunderstandings.
Closeout. Any observations are issued on Form 483.
Classification. FDA later classifies the inspection as NAI, VAI or OAI (FDA).

An inspection readiness plan

Area	Readiness actions
People	Named inspection lead, front room and back room roles, trained subject matter experts, scribes
Logistics	Inspection SOP, rooms, document request tracker, escalation path
Documents	Current procedures, organization charts, site master file, product and process lists
High-risk records	Complaints, deviations, OOS, CAPA, change control, supplier files, training, data integrity reviews
Inspectable reports	For devices: internal audit, supplier audit and management review reports written to be read by FDA
Practice	Mock inspections, including unannounced drills and remote document requests
Follow-up	483 response process ready to deliver within 15 business days

FDA inspection readiness checklist

Prepare with evidence, not guesswork

The hardest part of inspection readiness is knowing whether your documents would hold up. AskDona can assess procedures and records against FDA regulations, ISO 13485 or your own readiness checklist before investigators arrive, flagging gaps and citing the passage behind every finding.

Run a sample inspection readiness assessment on a high-risk procedure. AskDona shows the evidence; your team decides.

FAQ

What is an FDA inspection? An official onsite examination of a facility to determine compliance with FDA laws and regulations.

Is an FDA audit the same as an FDA inspection? People use both terms, but FDA calls it an inspection. It differs from a certification audit because it can lead to regulatory action.

Does FDA announce inspections? Domestic inspections are typically unannounced, and FDA has expanded unannounced inspections abroad since May 2025 (FDA).

What happens after an FDA inspection? Observations are issued on a Form 483, and FDA classifies the inspection as NAI, VAI or OAI.

How do I prepare for an FDA inspection? Maintain an inspection SOP, trained teams, current records, closed commitments and regular mock inspections.

References

All pages opened and checked by October 13, 2026.

Source	Type	Date	Used for
FDA: Inspection classifications	Regulator	Apr 18, 2024	Definition, outcomes
FDA: Types of FDA inspections	Regulator	Sep 13, 2024	Inspection types
Ropes & Gray: RRA guidance	Law firm	Jul 3, 2025	Remote assessments
FDA Voices: Inspectional enterprise	Regulator	Aug 3, 2026	Inspection counts, unannounced share
FDA: Unannounced foreign inspections	Regulator	May 6, 2025	Policy change
FDA: Elsa launch	Regulator	Jun 2, 2025	Targeting
FDA: One-day inspectional assessments	Regulator	May 6, 2026	New format
FDA: QMSR FAQ	Regulator	Oct 2, 2026	Device inspections
Food Safety Magazine: Foreign inspections	Trade press	Nov 6, 2025	Counter-trend
FDA: Investigations Operations Manual	Regulator	Jul 15, 2026	Investigator reference