The FDA May Be Coming Unannounced to Your Facility: Are You Ready?
Simona Mills, Sr. Director Q&C, ProPharma
Benjamin Frey, Vice President Q&C, ProPharma
An executive order was signed May 5, 2025, impacting the drug and medical device supply chain. Among other directives, beginning August 2025, the FDA will expand its inspection authority to include unannounced inspections of foreign manufacturers of drugs, biologics, medical devices, and diagnostics. This article explores the global implications of this policy shift and outlines practical steps organizations can take to embed inspection readiness into daily operations, culture, and quality systems.
Introduction:
On May 5, 2025, the President of the United States signed an executive order with far reaching impact on several agencies, including the FDA. Among other directives, beginning in August 2025, the U.S. Food and Drug Administration (FDA) will initiate unannounced inspections at non-U.S. manufacturing facilities involved in producing drugs, biologics, medical devices, and diagnostics intended for American consumers and patients. This shift in practice aligns foreign inspections with the FDA’s domestic approach and reflects growing expectations for continuous global regulatory compliance. Organizations with operations outside the United States—including manufacturing organizations (contract or otherwise), contract testing laboratories (CTLs), and clinical research sites—should be aware of the shift in tactic as they may all be directly in scope.
While this policy evolution is operational in nature, it also signals something more fundamental: a mindset shift. Inspection readiness can no longer be approached as an episodic activity for facilities outside of the United States. It must become a state of operational normalcy that is embedded into the culture, workflows, and systems of every regulated organization. Essentially, any company that is involved in supplying drug products, drug substances (or Active Pharmaceutical Ingredients), and medical devices to the US market must be inspection ready at all times to ensure uninterrupted access.
Why Unannounced Foreign Inspections?
As previously outlined, this policy change stems, in part, from the May 2025 U.S. Executive Order on Regulatory Relief to Promote Domestic Production of Critical Medicines, which mandates broader inspection authority, including unannounced inspections at foreign manufacturing sites (White House, 2025)¹. Among several provisions, it mandates the expansion of the FDA’s foreign inspection program to better mirror its domestic model. The Agency will also begin disclosing the annual number of foreign inspections conducted, reinforcing a commitment to transparency and aligning global expectations for quality and accountability.
The objective is not only enforcement. It is about ensuring that manufacturers, regardless of industry or location, are held to consistent standards of quality and accountability. The FDA is reinforcing its commitment to consistent and rigorous regulatory oversight across the global supply chain.
Inspection Outcomes: The Data Tells the Story
The frequency and nature of FDA findings underscore the importance of proactive compliance. In fiscal year 2024, the FDA issued more than 4,000 Form 483 observations, including 561 related to drugs, 49 related to biologics, and 672 related to medical devices (U.S. FDA, 2024)². FDA also issued 101 inspection-based Warning Letters for drug and biologics manufacturers, and 44 Warning Letters directed to medical device manufacturers. Other advisory actions were issued across bioresearch monitoring and human tissue for transplantation. Although not exhaustive, these figures reflect ongoing compliance gaps in both established and emerging facilities.
Among the most common inspection findings were:
- Inadequate deviation investigations
- Gaps in process or equipment validation
- Contamination control failures
- Missing or outdated standard operating procedures (SOPs)
- Data integrity concerns
- Stability program deficiencies
These issues are often interrelated and may point to broader challenges in managing complexity, scale, or change. More often, they reveal deeper problems in how organizations sustain effectiveness and control under real world conditions. In many cases, at facilities with such findings,
- Documentation exists but is either poorly implemented or inconsistently followed.
- Training is available but is too high-level or often rushed as a task to quickly complete in order to tackle so many others that are directly related to manufacturing or getting products out the door.
- Programs are implemented (Stability Program, Data Integrity Program, Validation Program) but not appropriately planned or executed in a timely manner.
What Inspectors Are Really Looking For
Today’s inspections go beyond evaluating documents and systems on paper. Inspectors assess whether compliance practices function as intended, are holistic, well planned, and intentional. Systems, programs, documents, etc. need to function well, even under pressure and without preparation. Inspectors observe how staff follow procedures, respond to questions, access and retrieve data, and maintain control of the process.
Compliance isn’t about passing a moment-in-time assessment. It’s about demonstrating, every day, that your systems are embedded, your data is reliable, and your people are inspection-ready. If an agency visits unannounced, the goal should be to respond confidently, reflecting systems and processes that are well-established and routinely followed.
This approach is grounded in compliance and experience and reflects a deeper understanding of regulatory engagement. It emphasizes the need for sustainable, holistic systems that perform under routine operation, not just in anticipation of Agency oversight.
Rethinking “FDA Ready”
The phrase “we’re always ready for an inspection” is commonly heard throughout the pharmaceutical and device industries. However, many organizations still treat readiness as a temporary state, achieved just before a scheduled audit. This reactive posture is increasingly risky under the FDA’s unannounced model.
True inspection readiness requires more than good intentions. It involves:
- Real-time performance of quality systems
- Cross-functional alignment across manufacturing, quality assurance, and regulatory teams
- Ongoing training and reinforcement of compliance expectations
- Internal accountability mechanisms that detect issues before regulators do
It is not about being flawless. Rather, it is about maintaining the ability to demonstrate operational control and compliance, and data integrity at any point in time.
Real-Time Readiness: What It Really Means
Real-time readiness means that an organization can confidently undergo a regulatory inspection without any prior notice or special preparation and perform well. It reflects a standard of day-to-day excellence, not just emergency responsiveness.
The benefits of real-time readiness are tangible. It protects:
- Patients, by ensuring the consistent availability of safe and effective products
- Timelines, by preventing delays to approval or commercialization
- Budgets, by reducing costly remediation and disruption
- Reputation, by reinforcing credibility with regulators and partners
An inspection failure, regardless of industry or location, can have far-reaching consequences. With new product development taking an average of 10 to 15 years, and many stakeholders involved along the way, a single inspection outcome can impact patients, staff, investors, and strategic plans.
Readiness Is an Ongoing Discipline
Being “inspection-ready” requires more than project-based initiatives. What may start as a project initiative at the very beginning of establishing an organization, in the long run, it is an organizational discipline and a state of mind that must be continuously maintained.
Companies that excel in this area share several common characteristics:
- An understanding that readiness is not subjective—it is measurable
- Clarity around roles, ownership, and expectations
- Routine assessment and internal auditing to maintain standards
- Investment in training and technology to support efficiency
When readiness becomes a routine part of operations, organizations build muscle memory that supports faster, more confident responses under real inspection conditions.
Immediate and Long-Term Actions to Improve Readiness
Building a real-time inspection readiness program requires a phased approach that incorporates tactical execution as well as long-term planning ahead of that execution.
Immediate Actions
- Readiness Assessments: Conduct gap analyses to understand where vulnerabilities exist.
- Remediation Programs: Close existing gaps through targeted actions, prioritizing areas with the highest compliance risk; therefore, those most likely to be scrutinized.
- Project Management Support: Assign dedicated resources to oversee the remediation and readiness timeline.
Long-Term Foundations
- Inspection Processes: Establish or update inspection strategies and logistics procedures.
- Training: Implement general inspection education for the entire facility and for critical vendors, implement and routinely refresh SME interview training, and conduct mock inspections to build staff confidence as well as identifying any new gaps.
- Process Ownership: Ensure clear roles are outlined and practices as to who will host inspections, manage requests and resources, interview on specific topics, and communicate findings.
Routine Quality Monitoring
- Facility Walkthroughs: Identify compliance issues in real time, before they become observations.
- Periodic SOP Reviews: Keep documentation relevant and aligned with current practices.
- Vendor Audits: Hold external partners to the same standards of readiness.
- Management Reviews: Use formal reviews to monitor key performance indicators and the health of systems.
The Broader Picture: Technology Transfers and Interconnected Risk
In addition to site-specific risks, many companies must also consider the implications of unannounced inspections when selecting future manufacturing, testing, and packaging sites. If technologies must be transferred to U.S.-based firms via tech transfer activities, firms may find themselves suddenly responsible for this process and the implications to future inspections. Transferring production from noncompliant, failing, or closing sister sites, or partners abroad into the U.S. is an arduous process that must take compliance and inspection readiness into account. This reinforces the need for every node in a global supply chain to be aligned with their commitment to readiness. Asking difficult questions, with respect to inspection readiness, during the initiation process of identifying a new manufacturing site may relieve difficult or even unsuccessful inspections in the future.
If foreign manufacturing is disrupted, activities such as testing, packaging, and distribution may need to shift back to U.S. facilities. The success of these transfers depends on the readiness of both sending and receiving sites. Failing to prepare in advance adds unnecessary complexity and risk.
A Culture of Readiness
Ultimately, inspection readiness is not simply a regulatory requirement. It is a reflection of an organization’s priorities, culture, and operational maturity. Readiness shows up in how decisions are made, how issues are escalated, and how consistently teams follow procedures.
Organizations that succeed in this area view inspections not as interruptions, but as validations of their routine compliance and excellence. They cultivate accountability, transparency, and performance at all levels of the organization.
Conclusion: The Time to Prepare Is Now
With unannounced inspections expanding globally, the pharmaceutical and medical device industries are entering a new era of regulatory oversight. Outcomes will no longer be private or delayed. The time to prepare is not when a notice arrives – the time is now.
Inspection readiness must become a strategic priority, integrated into the fabric of daily operations. Those who embrace it will gain a competitive advantage in quality, efficiency, and trust. Taking early, proactive steps allow organizations to manage change thoughtfully and with confidence.
Unannounced inspections simply reflect an opportunity to demonstrate how well systems function under routine conditions.
References
- Executive Order on Regulatory Relief to Promote Domestic Production of Critical Medicines, The White House, May 2025.
- U.S. Food and Drug Administration. Inspection Observations (Form FDA 483) Fiscal Year 2024 Summary. Available at: https://www.fda.gov
Simona Mills, PMP, is the Sr. Director of Product Lifecycle Management in the Quality and Compliance service line at ProPharma. She has over 23 years of industry experience in pharmaceuticals, biologics, and combination products. Simona’s expertise includes Validation, Quality, Quality Engineering, Regulatory Affairs, and Project Management. She leads Inspection Readiness/PAI Readiness services at ProPharma and has worked on Tech Transfer, Compliance/QMS, Remediation, and more. Simona studied Chemical Engineering at The Ohio State University and holds a PMP certification.
Benjamin Frey is the Vice President of Compliance and Quality Assurance at ProPharma, providing strategic leadership and technical expertise for the company’s Quality Assurance and Compliance initiatives. With over 30 years of experience in FDA-regulated industries, Benjamin has a proven track record of ensuring compliance with GMP requirements and quality management systems. His expertise spans Quality Assurance, Validation, and Quality Control, with a focus on risk-based, practical approaches to quality system development, auditing, and remediation. Benjamin has a B.S. and M.S. in Biology.
