Interactions with FDA Investigators: Dos and Don’ts

Professional Dos and Don’ts When Interacting with FDA Investigators

A US FDA inspection is not only a regulatory audit—it’s also a direct assessment of how your organization communicates, cooperates, and controls its operations. Inspectors carefully observe both documentation and human behavior. The way personnel engage during an inspection can significantly influence outcomes, escalate or de-escalate concerns, and either build or erode regulatory trust. This article outlines the key dos and don’ts when interacting with FDA investigators during GMP inspections to help your facility stay compliant and professional.

Why Interactions with FDA Inspectors Matter:

Behavior, transparency, and preparedness are interpreted as indicators of GMP maturity
Poor communication can raise suspicion, trigger additional requests, or result in enforcement
Effective interactions demonstrate control, accountability, and quality culture

DO: Prepare Your Inspection Team Thoroughly

Designate an Inspection Coordinator to handle logistics and document retrieval
Assign Subject Matter Experts (SMEs) for each functional area: QA, QC, manufacturing, engineering
Train staff on FDA inspection procedures, expected questions, and documentation protocols
Conduct mock audits to evaluate response accuracy, body language, and communication tone

Also Read: How to Appeal FDA Inspection Findings

DO: Be Transparent and Truthful

Answer questions honestly—never speculate or make assumptions
If unsure, say: “Let me verify that information and get back to you.”
Disclose deviations, CAPAs, or changes upfront if asked
Do not hide documents or redact information unless legally protected

DO: Follow Document Request Protocols

Log all document requests and maintain copies of what is provided
Ensure documents are current, approved, and match operational practices
Provide requested documents only through the Inspection Coordinator
Verify that records include necessary signatures, dates, and SOP references

DO: Demonstrate GMP Control

Show accurate batch records, logbooks, and deviation investigations
Ensure data integrity: no overwriting, falsification, or missing pages
Review stability data, trend reports, and calibration logs before inspection
Maintain a clean, labeled, and organized facility environment

DO: Treat Inspectors with Professional Courtesy

Greet the inspector and ensure they are comfortable
Avoid excessive small talk, but maintain a respectful tone
Provide breaks, water, or meals as appropriate, but avoid anything that may appear unethical
Do not pressure or influence inspectors regarding findings

DON’T: Argue or Challenge Inspectors Publicly

Disagreements should be handled professionally and off-record
If there is a factual error, address it in the Form 483 response with evidence
Never interrupt or confront an inspector in front of others
Dispute resolutions should involve the Inspection Coordinator and senior QA

Also Read: Key Differences Between US, EU, and WHO Inspection Approaches

DON’T: Over-Explain or Volunteer Unrequested Information

Stick to the question asked—avoid unnecessary elaboration
Do not offer unrelated documents or examples unless directly requested
Speculating can raise red flags or trigger unrelated lines of inquiry
Stay factual, brief, and on-topic

DON’T: Display Nervous or Defensive Behavior

Avoid crossing arms, avoiding eye contact, or whispering
Speak clearly and at a calm pace
Answer only what you know; it’s acceptable to defer questions to your SME
Body language matters—train employees on inspection presence and tone

DON’T: Delay or Hide Documents

Delays in document retrieval may be interpreted as a lack of control
Never provide drafts, unofficial versions, or unsigned documents
Do not modify or annotate documents after the inspection starts
All changes must follow GMP documentation protocols and audit trail rules

DON’T: Assume Previous Compliance Equals Current Acceptance

FDA expectations evolve—what passed in a prior inspection may not be acceptable now
Demonstrate current control, updated procedures, and continuous improvement
Rely on current SOPs, validated data, and inspection-readiness rehearsals

Also Read: Data Integrity Focus in FDA Inspections

Handling the Inspection Closeout Meeting:

Listen carefully to preliminary observations shared by the investigator
Take detailed notes—do not argue or interrupt
If asked to respond on the spot, keep it factual and acknowledge any valid findings
Ask for clarification if needed but avoid defensiveness

Post-Inspection Actions to Preserve Trust:

Respond to Form 483 within 15 working days with root cause, CAPA, and documentation
Avoid generic responses—include timelines and effectiveness checks
Maintain open communication with the FDA if follow-up is needed
Conduct a post-inspection debrief and update your training or audit SOPs accordingly

Conclusion:

Interactions with FDA investigators should be approached as an opportunity to demonstrate operational transparency, control, and compliance maturity. By practicing clear communication, controlled behavior, and documented procedures, pharmaceutical manufacturers can navigate inspections successfully and maintain regulatory trust. These professional dos and don’ts are not just about good manners—they are an extension of your GMP culture and quality systems discipline.