When the Food and Drug Administration (FDA) arrives for an inspection, laboratories must be ready to show that their data are defensible, their processes are consistent, and their quality systems are actively maintained. For many lab managers—especially those leading their first inspection—the experience can feel intimidating.
Two experts with firsthand insight into FDA expectations offered their perspectives to Lab Manager: Dan Rice, PhD, MS, senior advisor for food safety at The Acheson Group and former director of the FDA’s National Food Laboratory Program, and Gerome Burke, MD, PhD, medical toxicologist at Drugwatch.com and former program director for research and reporting at the FDA’s Center for Drug Evaluation and Research (CDER). Together, they explain how laboratory leaders can strengthen quality systems, build staff confidence, and turn inspections into opportunities for improvement.
What FDA inspectors look for during a laboratory compliance review
According to Burke, every inspection revolves around three foundational pillars: data integrity, process control, and the robustness of the laboratory’s quality management system (QMS). “The inspectors will start by looking for ALCOA+ data: Attributable, Legible, Contemporaneous, Original, and Accurate,” he says. “They will review electronic and paper records for data manipulation, poor documentation practices, or unusual data generation.”
Inspectors also verify that processes are well defined and consistently followed. “If a procedure is written, it must be followed exactly as documented,” Burke notes. This includes analytical method validation, equipment calibration, sample management, and reagent preparation.
Rice agrees that documentation is one of the first things inspectors examine. “Deficiencies often arise when people rely on cheat sheets or personal notes,” he says. “Everyone performing an analysis should be doing it the same way and using the same version of the method.”
How to keep systems calibrated and defensible for FDA inspection readiness
Rice emphasizes the importance of calibration and traceability for all instruments and measurement devices. “Everything you use to measure—balances, pipets, temperature monitoring devices—should be calibrated against a known standard, ideally traceable to NIST,” he says. Inspectors want to see not just that calibrations are done, but that they’re documented, routine, and performed by trained personnel.
Burke adds that modern inspections now extend well beyond paper logs. “FDA inspectors are now more technically trained and will review electronic systems, audit trails, user access logs, and data deletion records with more detail,” he says. “It is expected that all data generated is securely captured permanently, which is the focus of data integrity and data lifecycle management. FDA inspections are observing how the lab staff identify and control risks to product quality and data reliability throughout lab operations. Having a well-organized digital data infrastructure is now mandatory.”
Using internal lab audits and mock inspections to strengthen compliance
Both experts agree that inspection readiness should not be a one-time event. “Getting ready for an inspection shouldn’t be a heavy lift,” says Rice. “[Labs] should be ready for these assessments anytime.”
Burke recommends conducting regular mock audits. “The most effective strategy for lab managers is to conduct a mock audit using an internal or third-party expert to simulate the FDA inspection process. This can identify gaps that would need improvement prior to a real inspection,” he says.
“The goal is to confirm that all standard operating procedures (SOPs), training records, and calibration data are current, approved, and readily available,” he continues. Burke also suggests setting up a dedicated inspection area where requested documents can be provided promptly and designating specific roles for staff: one spokesperson, one note taker, one document retriever, and one overall coordinator.
Common deficiencies and CAPA process improvements to address early
Many of the most frequent inspection findings stem from lapses in basic quality practices. “Failure to follow established SOPs is a top citation,” Burke says, along with inadequate investigations. “When a deviation occurs, a root cause investigation must be completed,” he points out. "Operator error cannot always be the systemic cause.”
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Other recurring issues include weak data integrity controls, missing calibration records, and insufficient training documentation. Failing to maintain records that verify staff were trained on specific SOPs and instruments is a common and serious citation, Burke notes.
Rice has seen similar patterns throughout his career. “It’s really about having good, up-to-date records so that, when an inspector asks for them, you can generate and produce them,” he says. “It shouldn’t be a struggle.”
He also highlights the importance of timely corrective and preventive actions (CAPAs). “CAPAs shouldn’t stay open for years,” he says, pointing out that a strong quality system identifies the root cause, implements corrective action, and closes the loop.
Leadership and culture drive continuous inspection readiness
For both Rice and Burke, effective management sets the tone for inspection readiness. “Managers must communicate that quality is everyone’s responsibility, not just the quality assurance team,” says Burke. He advises managers to embed quality practices into daily workflows, use the QMS as an active management tool, and conduct regular self-inspections to keep standards high and make formal FDA audits feel routine.
Rice adds that communication and engagement are key to building staff confidence. “Everyone in the lab should understand their roles and responsibilities,” he says. “Consistent communication from leadership helps ensure that. And it’s critical to foster a non-punitive environment—if there’s a problem, it’s about the system, not the person.”
Training, they both note, should be ongoing and role-specific. “Conduct periodic refreshers of SOP training, especially when changes occur or errors are identified,” Burke advises. “Include ‘Inspection 101’ training for all staff, covering the basics of an interaction with an FDA inspector.”
Balancing documentation control with a practical quality management system
Rice cautions against overcomplicating the quality management system. “Some labs have an SOP or work instruction for everything,” he says. “There's a real balance between having what is necessary and maybe going overboard, putting time and energy into things that really aren't going to have a big payout.”
Burke agrees that efficiency is essential—but stresses that technology must be used responsibly. “A well-organized digital infrastructure is now mandatory,” he says. “FDA expects that all data generated is securely captured and traceable throughout the data lifecycle.”
Advice for first-time inspection leaders
When asked for their final advice, both experts emphasized preparation, honesty, and composure.
“Be proactive,” Burke says. “Don't wait for the FDA to find your problems. Use the lab’s QMS to identify and fix issues.”
“Be transparent,” he continues, meaning if the inspector finds an issue you already knew about, acknowledge it and explain your corrective action.
“And be the leader,” he adds. “If you are calm, prepared, and confident, the staff will follow.”
Rice echoes the same philosophy. “Inspectors are human,” he says, noting they share the goal of ensuring high-quality, defensible data. “An inspection is an opportunity to learn. Every independent assessment reveals something you can improve.”
Ultimately, both experts agree that readiness isn’t about perfection—it’s about progress. As Rice puts it, “The goal is continuous improvement. Labs should think of the current state as never the perfect state, and that there's always something they can do better.”
About the experts
Dan Rice, PhD, is a senior advisor for food safety at The Acheson Group and former director of the FDA’s National Food Laboratory Program, where he oversaw eight laboratories and about 600 staff. He previously led the New York State Food Laboratory and held academic research roles in community health and microbiology.
Gerome Burke, MD, PhD, is a medical toxicologist at Drugwatch.com and former program director for research and reporting at the FDA’s Center for Drug Evaluation and Research (CDER). He specializes in laboratory quality systems, data integrity, and regulatory compliance.
