Are FDA Investigators Truly Competent?

When I participated in an FDA inspection at a publicly listed company, the company president posed the following question during our preparatory meeting: “Are FDA investigators really that competent? Will following their recommendations actually improve our quality? After all, FDA investigators don’t manufacture pharmaceuticals themselves, nor do they design and produce medical devices.”

This skepticism is certainly understandable. However, there is a critical advantage that regulatory investigators and consultants like ourselves possess: we have examined the Quality Management Systems (QMS) of numerous companies and visited countless manufacturing facilities. This breadth of experience enables us to perform effective benchmarking and comparative analysis.

In other words, when a practice implemented at other companies is absent at the company under audit, this represents a potential risk. Similarly, if a company remains unaware of deviations or recall events that have occurred at other organizations, this also constitutes a significant risk.

The True Purpose of Inspections and Audits: Risk Identification

The fundamental value of inspections and audits lies in their ability to identify risks proactively. The FDA’s Investigations Operations Manual (IOM), updated in 2025, emphasizes that investigators are trained to identify systemic vulnerabilities rather than merely noting surface-level compliance issues. Modern regulatory oversight focuses on risk-based approaches that evaluate an organization’s capability to identify, assess, and mitigate quality risks throughout the product lifecycle.

What I frequently observe is that many audits focus solely on identifying past mistakes and problems. While addressing historical issues is certainly important, these should ideally be resolved by Quality Control (QC) or Quality Assurance (QA) functions before an audit takes place. The true purpose of an audit is not to discover problems but to verify that no problems exist and, more importantly, to identify potential future risks that the organization may not yet recognize.

The Challenge of Internal Auditors: Limited Benchmarking Capability

As mentioned above, audits must identify risks. However, long-serving employees who have spent their entire careers within a single organization will likely find it nearly impossible to identify these risks. This limitation stems from two fundamental issues:

First, they lack exposure to how other companies operate and what industry best practices look like. Without this external perspective, they cannot perform meaningful benchmarking.

Second, because they have internalized their own company’s methods as the “correct” way of doing things, they become blind to deficiencies, vulnerabilities, and potential hazards. This phenomenon, often called “organizational blindness” or “normalization of deviance,” is well-documented in quality management literature and has been implicated in numerous quality failures across industries.

Current Practices in Internal Auditing

In most companies, audits are conducted by following standardized audit checklists, checking off items, and searching for obvious problems. Furthermore, auditor training typically consists only of classroom-based group training sessions, often focusing on procedural requirements rather than developing true auditing expertise.

With such limited preparation, internal auditors cannot match the capabilities of experienced regulatory investigators who have conducted hundreds or thousands of inspections across diverse organizations and regulatory contexts.

FDA Investigator Qualifications and Training

To address the question posed at the beginning, it is worth understanding the qualifications and training that FDA investigators receive. According to FDA criteria and recent Government Accountability Office reports, FDA investigators (officially designated as Consumer Safety Officers) must possess at minimum a bachelor’s degree in science or engineering. They undergo extensive specialized training depending on their program area:

For drug manufacturing investigators:

• Basic Drug Manufacturing Quality Control Course
• Inspection of Active Pharmaceutical Ingredient Manufacturers Course
• Industrial Sterilization Training
• Minimum six months of on-the-job training using the FDA Investigational Training Manual

For medical device investigators:

• Basic Medical Device Training Course
• Process Validation or Industrial Sterilization Course
• Demonstrated competency in domestic inspections before conducting international inspections

For biologics investigators:

• Program-specific courses for blood banks, plasma centers, or biologics products
• Additional training in specialized areas such as cellular and gene therapies as applicable

Moreover, FDA investigators must demonstrate proven ability to communicate agency requirements, policies, and procedures effectively. They represent not only the FDA but also the U.S. government, requiring demonstrated professional demeanor and comprehensive knowledge of FDA’s laws, policies, and procedures. The 2025 IOM update emphasizes collaborative approaches and enhanced communication techniques during inspections.

Recent challenges include investigator workforce retention issues, with the FDA implementing enhanced compensation structures under Title 21 pay bands to address vacancy rates that reached concerning levels during and after the COVID-19 pandemic. Despite these challenges, the FDA maintains rigorous qualification standards to ensure investigator competence.

Developing Competent Internal Auditors: The Path Forward

So how should companies develop competent internal auditors? The answer is straightforward: conduct supplier audits extensively and build experience through repeated practice.

Crucially, companies should not limit their audits to poorly performing suppliers. They must also audit high-quality, well-performing suppliers. By conducting audits across a spectrum of supplier capabilities—from struggling organizations to industry leaders—auditors develop the benchmarking capability that is essential for effective risk identification.

Through repeated exposure to diverse organizations, auditors accumulate the comparative knowledge base necessary to recognize what constitutes good practice versus poor practice. They learn to identify early warning signs of systemic problems, understand how leading organizations approach difficult quality challenges, and recognize when their own organization’s practices fall short of industry standards.

Expanding Auditor Experience: Beyond Suppliers

In addition to supplier audits, organizations should consider several other approaches to develop auditor competence:

Participation in industry working groups and standards committees: Engagement with organizations such as the Parenteral Drug Association (PDA), International Society for Pharmaceutical Engineering (ISPE), or medical device industry associations provides exposure to emerging best practices and regulatory trends.

Cross-industry benchmarking visits: Formal arrangements to visit and learn from non-competing organizations in related industries can provide valuable insights. Many industry associations facilitate such exchanges.

External training with case study emphasis: Rather than generic classroom training, auditors benefit from programs that present real-world case studies from various organizations, particularly those involving FDA Warning Letters, consent decrees, or significant quality events.

Rotation programs: Where feasible, rotating quality professionals through different departments, sites, or even temporary assignments at supplier facilities builds broader perspectives.

Engagement with contract auditing: Some organizations have their internal auditors participate in third-party audits conducted by certification bodies or regulatory authorities as observers (where permitted), providing exposure to external audit techniques and findings.

The International Context: Harmonization and Mutual Recognition

It is worth noting that the FDA is not alone in its approach. International regulatory harmonization efforts through the International Medical Device Regulators Forum (IMDRF) and the Medical Device Single Audit Program (MDSAP) recognize that effective regulatory oversight requires investigators with broad exposure to multiple organizations and manufacturing contexts.

MDSAP, which allows a single audit to satisfy regulatory requirements for multiple countries (Australia, Brazil, Canada, Japan, and the United States), explicitly requires auditors to demonstrate competence across diverse regulatory frameworks and organizational contexts. This international recognition of the value of broad auditing experience reinforces the principle that exposure to multiple organizations is essential for developing auditor competence.

The Risk-Based Approach to Quality Management

Modern quality management systems, whether based on ISO 13485:2016 for medical devices or ICH Q9(R1) and Q10 for pharmaceuticals, emphasize risk-based approaches. Effective risk assessment requires understanding not only what could go wrong within your organization but also what has gone wrong at other organizations and why.

An auditor who has only seen their own company’s operations cannot effectively assess whether the organization’s risk assessments are comprehensive, whether mitigation strategies are appropriate, or whether monitoring activities are sufficient. They lack the comparative basis for such judgments.

The FDA’s own inspection approach, as detailed in the IOM, is fundamentally risk-based. Investigators prioritize their inspection activities based on product risk, firm history, and identified vulnerabilities. They look for systemic issues rather than isolated incidents, and they assess whether the organization’s quality system is capable of consistently producing safe and effective products. This sophisticated, risk-informed approach requires the broad perspective that comes only from examining many organizations.

Conclusion: Escaping the “Frog in a Well” Mentality

In Japanese, there is an apt expression: “井の中の蛙” (i no naka no kawazu)—the frog in a well. A frog that has spent its entire life in a well knows only the small circle of sky visible from the bottom. It cannot comprehend the vast world beyond.

Internal auditors who have experience only within their own organization are similarly limited. Without exposure to how other companies operate, what industry benchmarks look like, what problems have occurred elsewhere, and what solutions have proven effective, they cannot perform the kind of risk identification that FDA investigators routinely accomplish.

This is not a criticism of internal auditors’ dedication or intelligence. Rather, it is a recognition that effective auditing requires comparative knowledge that can only be built through exposure to multiple organizations and operational contexts.

To develop internal auditors capable of identifying risks as effectively as experienced FDA investigators, organizations must invest in building their auditors’ exposure to external benchmarks. Supplier audits across a range of high-performing and low-performing organizations provide the most direct path to developing this capability. Supplemented with industry engagement, external training focused on real-world case studies, and other mechanisms for building comparative knowledge, organizations can develop internal audit functions that truly add value through proactive risk identification.

Only by escaping the limitations of the “well” and gaining perspective on the broader landscape of quality management practices can internal auditors develop the competence to match that of experienced regulatory investigators. The question is not whether FDA investigators are competent—their systematic training, broad exposure, and demonstrated capability make clear that they are. The question is whether your internal auditors have been given the opportunities necessary to develop comparable competence.

Author’s Note: This article reflects perspectives developed through decades of experience in quality management, regulatory affairs, and consulting across pharmaceutical and medical device industries. The insights are based on participation in numerous FDA inspections, internal audits, and supplier assessments across Japan, the United States, Europe, and other regions.