How has the FDA's approach to overseas inspections changed in 2024-2025?

Between 2024 and 2025, the FDA shifted from pandemic-era stop-start inspection tactics to a sustained, more aggressive, data-driven, and technology-enabled oversight posture for foreign facilities. Key changes include increased foreign inspection coverage (with FY2024 showing a marked rise), formalization and expansion of remote regulatory tools (RRAs), pilot-to-policy rollout of unannounced foreign inspections, and the use of internal AI to help target inspections and accelerate review work. These changes aim to close the oversight gap between domestic and foreign inspections, prioritize high-risk supply chains, and reduce the time for regulatory decision-making, but they also raise operational, legal, and readiness implications for pharma and medical device and manufacturing organizations. This information is sourced from the Atlas Compliance tool. For more details, visit their website.

Top-Level Insights for 2024-2025

• FDA foreign inspections rose in scale and priority in FY2024, with more inspections focused on India, China, and other high-volume manufacturing hubs.
• The FDA moved permanent remote tools from pilot to policy (Remote Regulatory Assessments / RRAs and Remote Interactive Evaluations) and published final guidance in 2025 clarifying expectations. This formalizes a hybrid model (remote + on-site).
• The Agency announced plans to expand unannounced inspections for foreign facilities (May 6, 2025 announcement), building on pilots in India and China that began earlier. This narrows the "double standard" between inspections at home and abroad.
• FDA has begun integrating an internal generative AI tool ("Elsa") to improve prioritization and efficiency, including identifying high-priority inspection targets. Expect more data-driven triage and faster follow-up actions.
• Practical impact: more frequent and less predictable foreign on-site inspections, more regulatory records requests and remote assessments, and faster enforcement follow-up in some cases. Pharma and Medical Device manufacturers should shift from "inspection-ready" episodic behavior to continuous, data-backed audit readiness.

Background: Why the FDA changed course

Globalization of medicine and device supply chains means a large and growing proportion of FDA-regulated products are manufactured or sourced overseas. Concerns about product quality, incidents linked to imported products in prior years, and COVID-19 disruptions exposed weaknesses in the agency's ability to oversee foreign sites with the same intensity as domestic ones.

Two clear drivers pushed the FDA to change strategy in 2024-2025:

1. Inspection shortfall and capacity issues. GAO and FDA data showed inspection counts fell during and after the pandemic; the agency has been rebuilding capacity but still faces investigator shortages relative to need. The FY2024 and later activity reflects a concerted effort to close gaps.
2. New tools and political direction. Remote evaluations piloted in the pandemic matured into permanent tools (RRAs). Separately, the administration and FDA leadership pushed for parity between domestic and foreign oversight; one visible outcome was the move toward unannounced foreign inspections. Meanwhile, internal AI (Elsa) was introduced to improve efficiency and targeting.

What changed: the new components of the FDA's foreign-inspection posture

1) Quantitative increase in foreign inspections (FY2024 as inflection point)

The FDA's FY2024 reporting shows a significant rise in foreign drug quality assurance inspections and an increased share of all drug quality inspections occurring overseas. The FY2024 Report on the State of Pharmaceutical Quality notes that more than 62% of drug quality assurance inspections were at foreign sites, an all-time high and that India and China saw a sizeable uptick in inspections in FY2024. In absolute terms, CDER foreign inspections increased notably year-over-year (examples: 146 in FY2022 → 397 in FY2023 → 555 in FY2024 for FDA-conducted drug quality inspections).

What this means for manufacturers:

• Facilities in India and China (and other major sourcing countries) face a higher probabilistic risk of being inspected in a given fiscal year.
• Inspection planning must assume a higher baseline probability of audit and build continuous monitoring systems accordingly.

2) From pilots to policy: remote regulatory tools (RRAs and RIEs)

Remote regulatory assessments (RRAs) and Remote Interactive Evaluations (RIEs) began as pandemic-era stopgaps but were increasingly used to supplement on-site work. Between 2023 and 2025 FDA formalized RRA/RIE use, issuing final guidance and Q&As clarifying the scope, how records will be requested, what constitutes cooperation, and potential regulatory consequences of non-cooperation. RRAs reduce travel burden and allow faster document review, but the FDA's final guidance also safeguards the agency's ability to follow up with in-person inspections where necessary.

Operational implications:

• Expect more pre-inspection document pulls, remote trace reviews, and near-real-time camera or video walkthroughs as part of hybrid inspection models.
• Facilities should harden electronic document libraries, metadata, and remote access policies, and ensure traceability of records and chain-of-custody for images or video.

3) Expansion of unannounced foreign inspections

Historically, the FDA has used both announced and unannounced inspections domestically. Unannounced foreign inspections were piloted (India from 2022, China from 2023) and then expanded into a formal intent to widen their use (announced May 6, 2025). The stated aim: reduce opportunities for facilities to temporarily hide systemic non-compliance and to bring foreign inspection practices closer to domestic ones.

Risk and readiness impact:

• Supply-chain and production managers must plan for surprise visits, even in countries where local regulators historically received notice.
• Policies and practices that rely on "pre-inspection cleanup" are riskier; organizations must embed continuous compliance into daily operations.

4) Use of AI and data to prioritize and accelerate inspection work (Elsa)

In mid-2025 FDA launched an internal generative AI tool called Elsa, intended to assist scientific reviewers and investigators by summarizing data, identifying high-priority inspection targets, and accelerating reviews. Elsa is hosted in secure GovCloud, not trained on proprietary regulated data, but is already being used to triage and prioritize inspection targets and to accelerate protocol and safety reviews. This introduces a new upstream step in how inspections are selected and timed.

What to expect:

• FDA's inspection targeting will become more data-driven: adverse event trends, submission histories, inspection histories, and other structured/unstructured signals can be fed into models (human-supervised) to prioritize sites.
• Manufacturers should treat public and private signals (complaints, recalls, adverse events) as inputs that could fast-track attention from the agency.

5) Greater reliance on Mutual Recognition Agreements (MRAs), but with more active FDA verification

FDA continues to rely on MRA partners to accept certain inspections, but FY2024 shows both increased direct FDA inspections and MRA-classified inspections. The balance suggests the FDA is using MRAs strategically while still increasing direct oversight in areas it considers higher risk.

Deep dive: how the inspection process looks now (end-to-end)

1. Intelligence & prioritization. FDA analysts scavenge internal databases, public safety signals, and now Elsa-assisted summaries to produce a ranked list of inspection candidates. High-risk flags: product recalls, serious adverse events, prior OAI/483 trends, supply-chain concentration, and novel manufacturing technologies.
2. Pre-inspection engagement. For many facilities, the first contact is a records request or an RRA. The guidance documents define acceptable records, expected timelines, and modes of delivery. Where cooperation is limited or where remote data raises concerns, the FDA will escalate to an on-site inspection (possibly unannounced).
3. On-site inspection (announced or unannounced). Investigators now carry electronic inspection templates and may conduct parts of the inspection using hybrid methods (remote SME joins, near-real-time document uploads). Unannounced visits aim to see what is happening in operational reality rather than a prepared snapshot.
4. Post-inspection classification and follow-up. FDA's inspection outcomes (NAI, VAI, OAI) continue to be applied, but the expectation is for faster follow-up when gaps are severe. Elsa and other analytic tools can speed the analysis of inspection evidence, leading to quicker issuance of 483s, warning letters, or import alerts where warranted.

Atlas

See what the FDA knows about your next investigator.

30 minutes with the founder. No pitch deck.

See it live

The inspectorate and organization behind the change (who is doing the inspecting)

The FDA's inspection work is executed primarily by the Office of Regulatory Affairs (ORA) and the Office of Inspection and Investigations (OII), supported by center offices (CDER, CBER, CDRH) for technical expertise. To implement expanded foreign activity, the FDA has been increasing investigator presence overseas (e.g., efforts to station more drug investigators in India) and running pilot programs before policy rollouts. Country directors and regional staff coordinate logistics, legalities, and local engagement.

Practical note:

• Country offices and FDA investigators have greater autonomy and access to agency analytic tools. Companies should not assume inspections abroad are handled in the same low-profile way as before

Evidence and numbers you should know (selected data points)

• FY2024: >62% of drug quality assurance inspections were at foreign sites (all-time high), and FDA-conducted drug quality inspections rose (e.g., 555 in FY2024 for FDA-conducted drug quality assurance inspections).
• Pilots to unannounced: By May 2024 FDA had conducted 114 pilot inspections in India (94 unannounced) and 28 in China (16 unannounced) as part of pilots that later informed policy expansion.
• Inspection counts (post-pandemic context): GAO reported that in FY2023 FDA conducted 621 foreign and 444 domestic inspections (still lower than pre-pandemic levels) and recommended strategies to retain inspection capacity. That rebuilding contributed to the FY2024 uptick.
• AI adoption date: FDA publicly launched Elsa in June 2025 and reported early use-cases, including identifying high-priority inspection targets.

(Each number above is drawn from FDA reports and major reporting outlets; treat them as anchor points when building risk models and operational readiness.)

What this means for pharma and medical device manufacturers (practical actions)

1) Shift from episodic "inspection prep" to continuous compliance

• Embed inspection-readiness into daily operations. Think of inspections as likely and unpredictable rather than rare events.
• Maintain live SOPs, current training logs, near-real-time equipment calibration records, and validated e-document control systems that support remote pulls.

2) Harden electronic records and remote access

• Improve metadata, indexing, and version control. FDA's remote reviews expect rapid, defensible evidence delivery.
• Prepare for secure remote camera tours and controlled remote access sessions; establish an SOP for hosting remote investigators (who attend, what is shown, who moderates).

3) Intelligence hygiene and signal management

• Treat complaints, unexpected deviations, customer returns, and adverse events as visibility drivers; they feed into prioritization algorithms and human analysts.
• Proactively analyze trends, perform root-cause investigations, and document corrective/preventive actions (CAPA) with timestamps and evidence.

4) Plan for unannounced inspections

• Define a daily "inspection readiness" checklist that includes key personnel availability, critical batch records access, and a nominated single point of contact for unannounced inspection coordination.
• Conduct internal surprise audits to validate how systems and people behave under genuine surprise.

5) Legal and trade considerations

• Work with counsel to understand local laws on unannounced access, workers' privacy, and any diplomatic or customs procedures that could affect inspection logistics. FDA can and will conduct unannounced inspections under its authority, but local legal frameworks can influence practical execution.

Common industry questions and practical answers

Q: Will the FDA stop using MRAs and rely only on direct inspections?
A: No. FDA is still using MRAs, but it has increased direct inspections in areas it views as higher risk. MRAs remain a tool, not a substitute for direct oversight for all supply chains.

Q: Does Elsa mean the FDA will automate enforcement decisions?
A: Not at present. Elsa is an internal productivity tool to summarize and triage work. Final inspection and enforcement decisions remain human-led, though AI speeds analysis and prioritization.

Q: How immediate is the unannounced inspection expansion?
A: The FDA announced its intent on May 6, 2025; pilots began earlier (India 2022, China 2023). Implementation is staged and will continue to evolve with guidance and operational planning.

Risks and limitations of FDA's new approach (what to watch for)

• Operational strain on FDA: expanding unannounced inspections globally is resource-intensive; sustaining high coverage depends on hiring and investigator retention. GAO previously warned about capacity gaps.
• False positives and data-driven bias: automated signals can over-prioritize certain firms or geographies if the underlying data is biased or incomplete. Human oversight is necessary.
• Legal and diplomatic friction: unannounced inspections overseas can raise local concerns and require sensitive coordination. Expect industry pushback and negotiations in trade fora.

Checklist: 12 immediate steps for manufacturers (practical, high-priority)

1. Create a daily "inspection readiness" scoreboard (key records, critical personnel, environmental monitoring snapshot).
2. Harden e-document libraries: ensure searchability, version history, and exportable audit trails.
3. Build a secure, tested remote-inspection playbook (roles, data channels, communications).
4. Run internal unannounced mock inspections quarterly.
5. Review CAPA records for completeness and timeliness; close high-priority items.
6. Map supply chain concentration and consider dual sourcing for critical APIs or components.
7. Conduct an adverse-event and complaint data hygiene audit, and prepare narrative summaries that could be requested.
8. Train the shop floor on rights and processes during an unannounced inspection (who speaks, who escorts, photo/video rules).
9. Align legal, quality, and operations on a triage protocol for any FDA contact.
10. Update country-specific legal briefings (local labor/privacy rules for investigators on-site).
11. Simulate remote data pulls and measure time to produce requested documents.
12. Maintain a relationship with a regulatory consultant or counsel experienced in cross-border inspections.

Looking ahead: what might change next (2026 and beyond)

• More integrated AI-assisted targeting. Elsa-like tools will likely be refined and expanded; expect more integrated dashboards that combine surveillance, adverse events, and inspection histories to drive action.
• Hybrid inspections as the norm. A mix of RRAs and unannounced on-site inspections will become standard practice for high-risk facilities.
• Greater regulatory harmonization pressure. US policy changes will push trading partners and industry bodies to raise transparency and harmonize inspection readiness standards.
• Industry pushback and procedural clarifications. Expect litigation, negotiations, and additional FDA guidance as implementation nuances (e.g., scope of unannounced visits) are tested.