Preparing For FDA's Expanded Use Of Unannounced Inspections At Foreign Manufacturing Facilities

By Arif S. Noorani and Rachel C. Thomson, Sidley Austin

You’re a general manager or head of quality at a pharmaceutical manufacturer based outside the U.S., arriving at work ready to begin your typical challenging day, and you receive a call from security. Two investigators from the U.S. FDA have just walked in unannounced to begin an inspection of the facility. Inspections can be stressful, particularly when they come as a surprise, but don’t panic. There are key actions you can take now to be better prepared to host an unannounced inspection.

FDA’s Expansion Of Surprise Foreign Inspections

FDA announced on May 6, 2025, that it intends to expand its use of unannounced inspections at foreign manufacturing facilities that produce essential medicines and other medical products intended for American consumers and patients. The FDA’s announcement comes on the heels of President Trump’s Executive Order, issued on May 5, 2025, aiming to reduce regulatory barriers to the domestic production of medicines for American patients and calling for enhancements to the risk-based inspection of overseas manufacturing facilities. FDA’s announcement notes that the aim of expanding unannounced foreign inspections is to ensure that foreign manufacturers receive the same level of oversight and regulatory scrutiny as domestic manufacturers.

Domestic manufacturers always have been subject to unannounced inspections by FDA for compliance with good manufacturing practices (GMP). By contrast, FDA historically has contacted foreign manufacturers to schedule inspections, often weeks, and sometimes months, in advance, often due to the logistics of arranging international travel, including securing the necessary visas and interpreters, and the desire to have confirmation that the facility will be open upon the investigator’s arrival. Nearly 90% of FDA’s foreign inspections in fiscal 2023 were announced in advance. FDA has, however, experimented with unannounced foreign inspections in recent years. In March 2022, FDA began a pilot of surprise inspections limited to facilities in India and China. The objective of the pilot was to assess the effect of conducting unannounced versus pre-announced inspections, and the agency continued to conduct both announced and surprise inspections in parallel in those countries. The May 6, 2025, announcement expands the use of surprise inspections beyond the China and India pilot to any foreign manufacturer.

Although the FDA has signaled its intent to expand unannounced inspections globally, not all sites are equally likely to be targeted. Accordingly, companies should proactively assess their site-specific risk by considering factors that may place a facility higher on FDA’s inspection radar. These considerations include: the volume and value of products exported to the United States, GMP compliance history, time elapsed since the last FDA inspection, and the criticality of the products manufactured — particularly sterile injectables, biologics, and other complex dosage forms. Geographic location may also play a role; while the pilot program focused on India and China, facilities in countries with limited mutual recognition agreements or fewer prior inspections may be prioritized. A structured risk stratification can help senior leadership and quality teams justify the allocation of resources to enhance readiness at higher-risk sites.

Actions Companies Should Take Now To Prepare

There are proactive steps companies with foreign manufacturing facilities can take now to be prepared for these anticipated changes in the inspection environment. In theory, a surprise inspection should be no different than a scheduled inspection. After all, facilities are meant to be “inspection ready” at any given moment. In reality, when an investigator shows up unannounced, the management team will benefit from having taken measures to prepare for the inspection, in both logistics and substance.

In preparing, it is important to remember that the outcome of an inspection can be influenced by the logistics of how it is managed. An unreasonable delay in producing records, for example, can constitute a refusal to permit an inspection – a prohibited act under the U.S. Food, Drug, and Cosmetic Act (FDCA). Companies should follow the general guidelines below to ensure that the inspection management process is well defined and personnel are suitably prepared.

1. Appoint inspection hosts, scribes, and support teams. Prepare a contact list of key management and inspection support personnel, including subject matter experts (SMEs). A copy should be available at the security gate or front office with the contact details of the primary individuals to be notified immediately upon the arrival of FDA investigators. Be mindful that FDA has the authority to inspect the facility at reasonable times and within reasonable limits. If the facility operates over multiple shifts, it would be entirely reasonable for FDA investigators to arrive outside of regular office hours. Review your contact list periodically and keep it updated.

2. Develop and train on a “playbook” for backroom support. The back room is the central nervous system of the inspection. It receives the requests, collects the records to fulfill the requests, anticipates other requests based on the line of questioning, and prepares the SMEs for discussions with the investigator. It can be very useful to have a playbook for the backroom operations that can be used to train support personnel, including templates for managing requests and discussing key messages with SMEs in advance. Share point sites are useful to maintain tracking and fulfillment of document requests, capture live scribe notes of discussions, upload documents for shared review, and chat in real time regarding the topics under discussion. It is also important to involve legal counsel early in the inspection process to provide guidance on requests, ensure appropriate handling of sensitive documents, and advise on when confidentiality or regulatory boundaries may apply. Legal support can help reduce the risk of misstatements or over-disclosure, and contribute to the development of a response strategy in the event of inspectional observations.

3. Ensure inspection-ready access to digital systems with IT support. Given the FDA’s increasing reliance on electronic record systems during inspections, facilities must ensure digital readiness. This includes establishing preconfigured, read-only access profiles to key systems such as QMS (quality management system), LIMS (laboratory information management system), and MES (manufacturing execution system). Providing real-time access during the inspection — without compromising data integrity — can reduce delays and demonstrate operational maturity. Facilities should also designate IT personnel to be on call to troubleshoot access issues or demonstrate system functionality.

4. Prepare key documents and prepare SMEs for complex discussions. Before an investigator arrives, ensure that core documents are readily accessible and that SMEs are equipped to address challenging topics while maintaining confidentiality. Key documents likely to be requested include the Site Master File, index of procedures, Master Validation Plan, list of U.S.-approved products, and current production plan. Additionally, it can be helpful to prepare a short overview presentation — 15 to 20 minutes — introducing the facility’s history, layout, products, equipment, and QMS structure. Alongside these materials, SMEs should prepare for how they will present complex quality events, including root cause analysis and CAPA implementation. For more complex issues such as recalls, Field Alert Reports, or Biologic Product Deviation Reports, consider using storyboard-style visuals for clarity and consistency. Well-prepared documentation and well-spoken SMEs are equally vital to ensuring a smooth and credible inspection.

5. Bridge communication gaps with bilingual coordinators and pre-translated key documents. Communication gaps during inspections — especially in non-English-speaking regions — can slow down proceedings and inadvertently raise compliance concerns. Facilities should identify bilingual personnel to act as inspection coordinators. Where applicable, facilities should also pre-translate or create translated storyboards for key documents that are likely to be requested. Proactively addressing language and cultural barriers not only facilitates smoother interactions but also helps to demonstrate transparency to investigators.

6. Confirm effectiveness of corrective and preventive actions from prior inspections. If the facility was inspected by FDA previously, conduct an effectiveness check of the CAPAs implemented in response to any inspectional observations to minimize the risk of a repeat observation. If there were verbal discussion points from the previous inspection summarized in the Establishment Inspection Report (EIR), confirm that actions were taken to appropriately address them.

7. Analyze QMS metrics. Review and monitor QMS metrics to ensure timeliness of deviations, complaints, laboratory investigations, and stability testing in accordance with procedures. For any overdue deviations, investigations, or complaints, ensure there is an extension approved by the quality unit according to procedure. If there is a systemic backlog in any area, ensure that there is a documented plan to address it, including resource allocation and leadership oversight.

8. Monitor facility maintenance and cleanliness. Conduct frequent, vigilant facility walk-throughs to ensure the GMP areas and equipment are clean and fit for use. FDA investigators will almost always request to tour the facility as the first order of business, and it is critical that the facility shows well. This will be the investigator’s first impression of the operations at the site, and it sets the tone for the inspection. Facility cleanliness and suitability have featured heavily in recent FDA enforcement, with several warning letters issued in 2025 for failure to maintain facilities in a good state of repair, including pest infestation, manufacturing areas open to the outdoor environment, heavily soiled washrooms, lack of soap for handwashing, dirty gowning rooms, and product residue on equipment labeled as clean.

To avoid having your facility suffer the same outcome, institute regular facility walk-throughs of the GMP areas by a cross-functional team, including production, maintenance, and quality. Develop inspection checklists to facilitate consistency and thoroughness, and initiate maintenance work orders (and potentially deviations) when issues are observed. Have rotating members of the management team accompany these walk-throughs periodically; it is important to the company’s quality culture to show their presence and engagement to personnel on the shop floor.

9. Benchmark recent inspection observation trends. Understanding what topics have been of recent concern to FDA investigators will help you to focus your preparations. Warning letters are publicly available, as are many Form FDA-483s (“List of Inspectional Observations”). Leverage inspection trends that may already be compiled within your corporate quality network or engage a third-party expert or regulatory counsel to do benchmarking.

10. Conduct a mock inspection. Use internal auditors or independent third parties to simulate an unannounced FDA inspection, with multiple auditors, to challenge the inspection management logistics and SME readiness. This is an opportunity to self-identify potential issues, if present, and address them ahead of an FDA inspection, as well as to improve SME interactions with investigators.

Effective preparedness does not end when the investigators walk out the door. Conducting a daily internal debrief is a critical best practice. This allows the inspection team to discuss investigator focus areas and address potential observations. Debriefs should involve all SMEs, backroom personnel, and quality and legal leadership to ensure a comprehensive view of the inspection experience. Lessons learned from these sessions can then be translated into CAPAs, refinements to playbooks, and updated training materials, contributing to a cycle of continuous improvement that strengthens inspection readiness over time.

Finally, it is also important to have a post-inspection plan in the event the company receives an FDA-483. Consider developing a plan and a template for preparing responses to any inspectional observations. Time is of the essence — responses must be submitted within 15 working days — so having a well-defined plan and milestones for drafting the response, including time for management and legal review and subsequent revisions prior to submission, is critical.

About The Authors:

Arif S. Noorani is a partner in Sidley Austin LLP's Food, Drug and Medical Device practice, based in Singapore and Washington, D.C. Noorani counsels life sciences companies around the world on FDA compliance, enforcement, and regulatory strategy. His work spans the product lifecycle — from clinical trials and quality systems oversight to GMP/QSR inspections, safety reporting, field actions, and post-inspection responses and remediation. He also advises on regulatory risk in investments and transactions, and defends clients in investigations and enforcement actions brought by the Food and Drug Administration, the Department of Justice, and other government agencies.

Rachel C. Thomson is a managing associate in Sidley Austin LLP's Food, Drug and Medical Device practice and is based in Washington, D.C. She advises pharmaceutical, biologic, and medical device companies on a range of regulatory compliance and enforcement matters. Prior to Sidley, Thomson was the executive director for a pharmaceutical consulting firm, where she provided experienced GxP compliance consulting to domestic and international clients in pharmaceutical and biotech manufacturing.